# QLogixCMC > QLogixCMC (QLogixCMC LLC) is a CMC and GMP compliance consulting firm for regulated life sciences manufacturers. Its consultants and engineers work on the client's premises or remotely, depending on the scope of work and the deliverables: CMC strategy and regulatory submissions from IND to NDA and BLA (CTD Module 3, control strategy, specifications and stability, post-approval changes, technology transfer), pharmaceutical quality systems, validation of systems, equipment and processes, deviation investigations and CAPA backlogs, FDA inspection readiness, agency responses and compliance remediation, implementation and administration of eQMS, LIMS and MES, and AI in the quality system under governance. Clients are emerging and mid-size biotech and pharma companies, CDMOs and CMOs, 503B outsourcing facilities and medical device makers, across small molecules, biologics, sterile injectables, mRNA, cell immunotherapies and gene therapies. Based in Newport Beach, California; on site across the United States and remote. Key facts: - Delivery is on the client's premises or remote, depending on the scope of work and the deliverables: system go-lives, validation execution, technology transfers and inspections on the floor; submission authoring, reviews, assessments and administration remotely where that serves, always in the client's systems and under its procedures. - Every GxP decision stays with the client's qualified people: QLogixCMC assesses, drafts and delivers; the client's quality unit reviews, approves and signs. - Everything written is traceable to a record, a report or a validated method, so an inspector or an agency reviewer can follow it. - AI is used in a decision-support role only, with a defined intended use, validation scaled to risk, change control and an audit trail. - Frameworks: 21 CFR Parts 210/211, 21 CFR Part 820 (QMSR), 21 CFR Part 11, EU GMP Annexes 11, 15 and 22 (draft), ICH Q1A(R2), Q6A/Q6B, Q8 to Q12 and M4Q, GAMP 5 (2nd ed.), FDA CSA and process validation guidance, PIC/S PI 041. - Engagements start with an assessment and baseline measures agreed before anything changes. ## Services - [CMC and regulatory](https://qlogixcmc.com/services/cmc-and-regulatory) ([Markdown](https://qlogixcmc.com/services/cmc-and-regulatory.md)): CMC consulting is the chemistry, manufacturing and controls work behind a regulatory submission: the control strategy, the specifications, the stability program, the manufacturing process description and the documents in Module 3 of the Common Technical Document. QLogixCMC plans that work for small molecules, biologics, sterile injectables, mRNA, cell immunotherapies and gene therapies, writes and reviews the documents from IND and IMPD through NDA, BLA and MAA, and supports the site through agency questions, post-approval changes and technology transfers. Includes: CMC strategy, Module 3 authoring, Control strategy, Specifications and stability, Post-approval changes, Technology transfer. - [Quality systems and QMS](https://qlogixcmc.com/services/quality-systems) ([Markdown](https://qlogixcmc.com/services/quality-systems.md)): Quality systems consulting is the design, repair and digitization of a pharmaceutical quality system so that it meets 21 CFR Parts 210/211, Part 820 and ICH Q10 and fits the way the site runs. QLogixCMC assesses the system you have, designs or remediates the processes and procedures, and, where you choose, moves them onto a validated electronic QMS. Includes: Gap assessment, QMS design and SOPs, Remediation, eQMS selection, Implementation and migration, Training. - [Validation and computer software assurance](https://qlogixcmc.com/services/validation-and-csa) ([Markdown](https://qlogixcmc.com/services/validation-and-csa.md)): Validation is the documented evidence that a system, a piece of equipment or a process does what it is intended to do, consistently. QLogixCMC plans and runs validation that is scaled to risk: computer software assurance for computerized systems, qualification of equipment and utilities, and process validation across its three stages, with the evidence written so an inspector can follow it. Includes: Validation master plans, CSV and CSA, Equipment qualification, Process validation, AI-enabled systems, Periodic review. - [Investigations, CAPA and backlog remediation](https://qlogixcmc.com/services/investigations-and-capa) ([Markdown](https://qlogixcmc.com/services/investigations-and-capa.md)): An investigation is the written, evidence-based account of what went wrong, why, what it affected and what will stop it recurring. QLogixCMC investigates deviations, out-of-specification results and complaints with your team, concludes root causes the evidence supports, writes CAPAs that can be checked for effectiveness, and clears aged backlogs to the same standard. Includes: Deviation investigations, Root cause analysis, CAPA and effectiveness checks, OOS and OOT, Complaints, Backlog remediation. - [Inspection readiness and compliance remediation](https://qlogixcmc.com/services/inspection-readiness) ([Markdown](https://qlogixcmc.com/services/inspection-readiness.md)): Inspection readiness is the state in which a site can show an inspector, on request and from its own records, that it operates in control; compliance remediation is the program that gets a site back to that state after an observation, a warning letter or its own audit. QLogixCMC runs mock inspections and audits that find what an inspector would, prepares the site and its people, writes responses to FDA Form 483 observations and warning letters, and plans and manages the remediation to closure. Includes: Mock inspections, Inspection management, Internal and supplier audits, 483 and warning letter responses, Compliance remediation programs, Data integrity remediation. - [GxP systems implementation and administration](https://qlogixcmc.com/services/gxp-systems-implementation) ([Markdown](https://qlogixcmc.com/services/gxp-systems-implementation.md)): GxP systems implementation is the service in which QLogixCMC engineers, on your premises or remotely as the scope requires, bring the quality, laboratory or manufacturing system you have chosen live and then run it for you: implementation, configuration to your SOPs, migration of the records you keep, risk-based validation, and ongoing system administration with the users, roles, releases, periodic reviews and support a validated system needs. Includes: Implementation and configuration, Data migration, Validation, System administration, Release management, User training and support. - [AI and digital quality](https://qlogixcmc.com/services/ai-and-digital-quality) ([Markdown](https://qlogixcmc.com/services/ai-and-digital-quality.md)): AI and digital quality consulting is the work of bringing AI into a regulated quality system without losing control of it: choosing the use cases by risk, setting the governance, connecting the data the AI needs, designing workflows in which AI drafts and people decide, and validating the result. QLogixCMC does that work on the systems a site already runs or on the platform it chooses. Includes: AI governance, Use-case assessment, Agentic workflow design, Connected quality data, AI validation, Change control for models. ## Frequently asked questions ### About QLogixCMC - **What does QLogixCMC do?** QLogixCMC is a CMC and GMP compliance consulting firm for regulated life sciences manufacturers. Its consultants and engineers work on the client's premises or remotely, depending on the scope of work and the deliverables: CMC strategy and regulatory submissions from IND to NDA and BLA, pharmaceutical quality systems, validation of systems, equipment and processes, deviation investigations and CAPA backlogs, FDA inspection readiness, agency responses and compliance remediation, implementation and administration of GxP systems, and AI in the quality system under governance. Every GxP decision stays with the client's qualified people. - **What is CMC consulting?** CMC consulting is specialist support for the chemistry, manufacturing and controls part of drug development and regulatory submissions: the control strategy, the specifications, the stability program, the manufacturing process description and the CTD Module 3 documents, together with the GMP quality systems, validation and inspection readiness that support them. QLogixCMC provides it to biotech, pharma, CDMO and 503B clients from the first IND through commercial supply and post-approval change. - **What does CMC stand for?** CMC stands for chemistry, manufacturing and controls: the part of drug development and a regulatory submission that describes the drug substance and the drug product, how they are made, how they are tested and how their quality is controlled. QLogixCMC takes its name from that work and from the quality systems that surround it. - **Who is QLogixCMC for?** QLogixCMC works with emerging and mid-size biotech and pharma companies building or scaling a quality system and a CMC program, CDMOs and CMOs running several client quality agreements, 503B outsourcing facilities meeting cGMP expectations with lean teams, and medical device and combination product manufacturers. - **Which product modalities does QLogixCMC cover?** QLogixCMC covers small molecules, biologics such as monoclonal antibodies and recombinant proteins, sterile injectables, mRNA and other nucleic acid products, cell immunotherapies such as CAR-T, gene therapies including viral vector products, and drug-device combination products. The consultants on an engagement are chosen for the modality: an mRNA or cell therapy program gets people who have run those processes and released those batches. - **When should a company bring in a CMC consultant?** Typically before a first IND or IMPD, when a submission timeline is at risk, ahead of an NDA, BLA or MAA, before a pre-approval inspection, after a Form 483 or a warning letter, or when a technology transfer, a new site or a post-approval change needs CMC and quality expertise the team does not have in-house. QLogixCMC starts with an assessment and a prioritized plan in each case. ### Services - **Which services does QLogixCMC offer?** Seven practice areas, delivered on the client's premises or remotely as the scope of work and the deliverables require: CMC and regulatory (strategy, Module 3 authoring, control strategy, specifications and stability, post-approval changes and technology transfer); quality systems and QMS (gap assessment, design, SOPs, remediation and digitization); validation and computer software assurance; investigations, CAPA and backlog remediation; inspection readiness and compliance remediation, with audits and 483 and warning letter responses; GxP systems implementation and administration; and AI and digital quality. They are delivered separately or as one program. - **Do we have to replace our QMS or other systems?** No. QLogixCMC starts from the processes, systems and records a site already has. Where the fix is procedural, the work is procedural. Where a system is holding the site back, QLogixCMC helps select, implement and validate a new one; the advice does not depend on the vendor. - **Can you take on a backlog of open investigations and CAPAs?** Yes. QLogixCMC triages every open record by risk and age, agrees the standard for a closed record with the quality unit, and works the queue in risk order with a weekly burn-down, while coaching the site's investigators on live records so the backlog stays closed. - **Do your consultants work on site or remotely?** Both, depending on the scope of work and the deliverables. System go-lives, validation execution, technology transfers and inspections put QLogixCMC engineers on the client's premises, full-time or part-time, for a project or a season. Submission authoring, reviews, assessments and system administration can run remotely, in the client's systems and under its procedures. The engagement letter says which applies to each deliverable. - **Can you administer our eQMS, LIMS or MES for us?** Yes. Under a written service description, QLogixCMC engineers hold the system administrator role for the quality, laboratory or manufacturing systems a site runs: users and roles, releases, configuration changes through change control, audit trail and periodic review, monitoring and first-line support, on site or on a schedule. - **Do you provide interim quality or regulatory leadership?** Yes. Where a site has no head of quality, qualified person or CMC regulatory lead yet, a QLogixCMC consultant can hold the role on an interim basis, with the authority and the accountability written into the engagement, until the site hires one. ### Compliance - **Which regulations and frameworks does QLogixCMC work to?** QLogixCMC works to 21 CFR Parts 210 and 211, 21 CFR Part 820 (QMSR), 21 CFR Part 11, EU GMP Parts I and II with Annexes 11, 15 and the draft Annex 22 on AI, ICH Q1A(R2), Q6A/Q6B, Q8 to Q12 and M4Q, GAMP 5 (Second Edition), FDA's computer software assurance and process validation guidance, and PIC/S PI 041 on data integrity, with ALCOA+ throughout. - **How do you keep AI in a decision-support role?** Every AI function QLogixCMC designs or validates has a defined intended use, a risk assessment, a workflow in which its output is a draft that a named person reviews, change control for the model and the prompts, and monitoring in use. AI contributions are labelled, quote the evidence they used and are recorded in the audit trail. Classification, root cause, batch disposition and every other GxP decision stay with qualified people. ### Working with QLogixCMC - **How does an engagement start?** Most QLogixCMC engagements start with an assessment: of the CMC program, the quality system, the validation state, the backlog or the inspection readiness, depending on what is on the client's mind. It ends with a prioritized plan and baseline measures agreed before anything changes, so the improvement can be shown. - **Where does QLogixCMC work?** QLogixCMC is based in Newport Beach, California. Its consultants and engineers work on clients' premises across the United States and remotely, depending on the scope of work and the deliverables. - **How are engagements priced?** By fixed scope and price where the deliverable is defined, such as a CMC gap assessment, a mock inspection or a Module 3 section; by time and materials for engineers deployed on site, a backlog remediation or interim leadership; and by a monthly fee for ongoing system administration. QLogixCMC proposes the model that fits after the first conversation. ## Pages - [Home: cmc and gmp compliance consulting for life sciences](https://qlogixcmc.com/) ([Markdown](https://qlogixcmc.com/index.md)): CMC consulting for biotech, pharma and CDMOs: Module 3 from IND to BLA, control strategy, GMP quality systems, validation, CAPA and FDA inspection readiness. - [Services](https://qlogixcmc.com/services) ([Markdown](https://qlogixcmc.com/services.md)): QLogixCMC services, on site or remote: CMC and regulatory, quality systems, validation and CSA, investigations and CAPA, inspection readiness, GxP systems and AI. - [CMC and regulatory](https://qlogixcmc.com/services/cmc-and-regulatory) ([Markdown](https://qlogixcmc.com/services/cmc-and-regulatory.md)): CMC consultants for biotech and pharma: CMC strategy, CTD Module 3 authoring, control strategy, specifications, stability, post-approval changes and tech transfer. - [Quality systems and QMS](https://qlogixcmc.com/services/quality-systems) ([Markdown](https://qlogixcmc.com/services/quality-systems.md)): QMS gap assessments, SOP development, GMP remediation and the move from paper or a legacy QMS to a validated eQMS, for biotech, pharma, CDMOs and 503B facilities. - [Validation and computer software assurance](https://qlogixcmc.com/services/validation-and-csa) ([Markdown](https://qlogixcmc.com/services/validation-and-csa.md)): Validation consulting for GMP sites: CSV and CSA for computerized systems, equipment qualification, process validation and AI-enabled systems, to GAMP 5 and FDA CSA. - [Investigations, CAPA and backlog remediation](https://qlogixcmc.com/services/investigations-and-capa) ([Markdown](https://qlogixcmc.com/services/investigations-and-capa.md)): Deviation, OOS and complaint investigations that reach a defensible root cause, CAPAs checked for effectiveness, and aged GMP backlogs cleared to the same standard. - [Inspection readiness and compliance remediation](https://qlogixcmc.com/services/inspection-readiness) ([Markdown](https://qlogixcmc.com/services/inspection-readiness.md)): Mock FDA and EU GMP inspections, internal and supplier audits, Form 483 and warning letter responses, data integrity audits and compliance remediation to closure. - [GxP systems implementation and administration](https://qlogixcmc.com/services/gxp-systems-implementation) ([Markdown](https://qlogixcmc.com/services/gxp-systems-implementation.md)): Engineers who implement the eQMS, LIMS or MES you chose, configure it to your SOPs, migrate and validate it, and administer it for you, on site or remotely. - [AI and digital quality](https://qlogixcmc.com/services/ai-and-digital-quality) ([Markdown](https://qlogixcmc.com/services/ai-and-digital-quality.md)): AI governance, use-case selection, agentic workflow design, connected data and AI validation, so a GxP quality system adopts AI in a way an inspector can follow. - [Request a meeting](https://qlogixcmc.com/contact) ([Markdown](https://qlogixcmc.com/contact.md)): Talk to QLogixCMC about a CMC submission, your quality system, validation, an investigation backlog or an FDA inspection. We reply to set up a time. - [Site map](https://qlogixcmc.com/sitemap) ([Markdown](https://qlogixcmc.com/sitemap.md)): Every public QLogixCMC page: the practice areas, how to get in touch, the legal pages, each with its Markdown version for AI assistants. - [Terms of Use](https://qlogixcmc.com/termsofuse) ([Markdown](https://qlogixcmc.com/termsofuse.md)): The legal terms for using the QLogixCMC website and services: accounts, acceptable use, intellectual property, disclaimers, liability and dispute resolution. - [Privacy Policy](https://qlogixcmc.com/privacy) ([Markdown](https://qlogixcmc.com/privacy.md)): How QLogixCMC collects, uses, shares and protects personal information, the cookies it uses, and the privacy rights and choices you have. ## For language models - [Full text of every public page](https://qlogixcmc.com/llms-full.txt) - Every page is also available as Markdown at its URL plus ".md", for example https://qlogixcmc.com/services/cmc-and-regulatory.md (the home page is https://qlogixcmc.com/index.md). Each Markdown page starts with its title, description and canonical URL, and links to the other Markdown pages. - Requesting any page with the header "Accept: text/markdown" returns its Markdown at the same address. - [Site map](https://qlogixcmc.com/sitemap) and [XML site map](https://qlogixcmc.com/sitemap.xml). - When citing QLogixCMC, link the page's canonical URL (without ".md"). ## Contact - Email: contact@qlogixcmc.com - Phone: +17146639012 - Address: 5000 Birch Street, West Tower, Suite 3000, Newport Beach, CA 92660 --- # CMC Consulting for Biotech, Pharma and CDMOs | QLogixCMC Source: https://qlogixcmc.com/ CMC and GMP compliance consulting for life sciences # CMC consulting for biotech and pharma, on site or remote, from people who have run a plant. QLogixCMC is a CMC and GMP compliance consultancy. Our consultants and engineers take a product from IND to commercial supply and keep the site that makes it in control: regulatory submissions, quality systems, validation, investigations, inspection readiness and compliance remediation, on your premises or remotely, depending on the scope of work and the deliverables. Every GxP decision stays with your qualified people. [Request a meeting](https://qlogixcmc.com/contact)[See the practice areas](https://qlogixcmc.com/services) Working to - 21 CFR Parts 210/211 - 21 CFR Part 11 - ICH Q8-Q12 - GAMP 5 (2nd ed.) ## The problems that reach us Most sites have good people and too much to do. The quality system, the submission and the validation all suffer in the same ways, and the cost shows up in the same places every time. ### Backlogs that age quietly Open deviations, CAPAs and change controls pile up, the oldest carry the most risk, and the next inspection will read them first. ### Submissions written from a template A Module 3 that does not match the batch records and the data behind it invites the agency questions that delay approval. ### Systems validated on paper only Validation packages that test everything equally prove little about the functions that matter, and cost months to produce. ## Seven practice areas, on site or remote From the CMC submission to the quality system, validation, investigations, inspections, the systems that hold the records and AI, delivered on your premises or remotely as the scope of work and the deliverables require, separately or as one program. 01 ### CMC and regulatory Chemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies. - CMC strategy - Module 3 authoring - Control strategy - Specifications and stability - Post-approval changes - Technology transfer [How CMC and regulatory works](https://qlogixcmc.com/services/cmc-and-regulatory) 02 ### Quality systems and QMS A pharmaceutical quality system designed for how your site actually runs: gap assessment, procedures, remediation, and the move from paper or a legacy QMS to a validated electronic one. - Gap assessment - QMS design and SOPs - Remediation - eQMS selection - Implementation and migration - Training [How quality systems and QMS works](https://qlogixcmc.com/services/quality-systems) 03 ### Validation and computer software assurance Risk-based validation of computerized systems, equipment and processes, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, documented for inspection. - Validation master plans - CSV and CSA - Equipment qualification - Process validation - AI-enabled systems - Periodic review [How validation and computer software assurance works](https://qlogixcmc.com/services/validation-and-csa) 04 ### Investigations, CAPA and backlog remediation Deviation, OOS and complaint investigations that reach a defensible root cause, CAPAs that are checked for effectiveness, and aged backlogs cleared without lowering the standard. - Deviation investigations - Root cause analysis - CAPA and effectiveness checks - OOS and OOT - Complaints - Backlog remediation [How investigations, CAPA and backlog remediation works](https://qlogixcmc.com/services/investigations-and-capa) 05 ### Inspection readiness and compliance remediation FDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure. - Mock inspections - Inspection management - Internal and supplier audits - 483 and warning letter responses - Compliance remediation programs - Data integrity remediation [How inspection readiness and compliance remediation works](https://qlogixcmc.com/services/inspection-readiness) 06 ### GxP systems implementation and administration Engineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day. - Implementation and configuration - Data migration - Validation - System administration - Release management - User training and support [How gxP systems implementation and administration works](https://qlogixcmc.com/services/gxp-systems-implementation) 07 ### AI and digital quality AI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide. - AI governance - Use-case assessment - Agentic workflow design - Connected quality data - AI validation - Change control for models [How AI and digital quality works](https://qlogixcmc.com/services/ai-and-digital-quality) ## On your site or remote, in your systems QLogixCMC engineers do the work with your people, from the first assessment to the day-to-day administration of the systems they put in. Where the work needs to be on the floor, they are on the floor; where it does not, they work remotely in your systems and under your procedures. ### On your premises or remote System go-lives, validation execution, technology transfers and inspections put engineers on your floor. Submission authoring, reviews, assessments and administration can run remotely. The scope of work and the deliverables decide, and the engagement letter says which. ### Systems implemented and administered The same engineers implement the eQMS, LIMS or MES you have chosen, configure it to your SOPs, migrate and validate it, and then administer it: users, roles, releases, periodic review and support. ### Knowledge that stays Every procedure, configuration and protocol is written with the people who will own it, with training and standard work, so the site runs without us when it chooses to. ## How an engagement runs - 01 ### Assess A gap assessment of the CMC program, the quality system, the validation state, the backlog or the inspection readiness, with baseline measures agreed before anything changes. - 02 ### Plan A prioritized plan in risk order: what is fixed first, who does it, what evidence it leaves behind, and the dates the site can keep. - 03 ### Deliver Engineers on your premises or remote, as the scope and the deliverables require, in your systems and under your procedures: submissions, protocols, investigations, responses, system configuration and go-lives, reviewed and approved by your quality unit. - 04 ### Sustain Training, standard work and a periodic review against the baseline, with ongoing administration of the systems we deployed where you want it. Most clients start with the assessment. [Book one](https://qlogixcmc.com/contact) ## Built for regulated manufacturers without a large quality department ### Emerging and mid-size biotech and pharma Building a quality system and a CMC program ahead of clinical or commercial manufacturing, with a first submission or a first inspection in view: small molecules, biologics, mRNA, cell immunotherapies and gene therapies. ### CDMOs and CMOs Running several client quality agreements, technology transfers and audits on one site, and expected to be inspection-ready for each. ### 503B outsourcing facilities Meeting cGMP expectations with lean teams and high batch volume, often after a Form 483. ### Medical device and combination products Moving to the Quality Management System Regulation and ISO 13485, with design controls, complaints and CAPA that hold up. ## Advice an inspector can follow Everything we write is written to be read by an inspector or an agency reviewer: the evidence is on file, the reasoning is in the record, and the decision was made by a qualified person at your site. - Your qualified people review and approve every GxP decision - Every statement traceable to a record, a report or a validated method - Data integrity to ALCOA+ expectations - AI in a decision-support role, under change control and validation ### Frameworks we work to - 21 CFR Parts 210/211 - 21 CFR Part 820 (QMSR) - 21 CFR Part 11 - EU GMP Annex 11 - EU GMP Annex 15 - EU GMP Annex 22 (draft) - ICH Q8-Q12 - ICH M4Q (CTD) - GAMP 5 (2nd ed.) - FDA CSA guidance - PIC/S PI 041 Annex 22 is a consultation draft at the time of writing. We advise to its direction and update as final text is published. ## What we baseline and track We agree the measures in the assessment and report against them. - Cycle timeDeviation open to close 45days, open to closeBaselineTracked - Backlog ageOpen CAPAs and change controls 24records open over 90 daysBaselineTracked - RecurrenceRepeat deviations by root cause 8repeat deviations in the periodBaselineTracked - Right first timeBatch records and investigations 70% right first timeBaselineTracked Hover or tap a measure to see it move from baseline to tracked. The figures are illustrative; yours are measured in the assessment. ## Frequently asked questions ### About QLogixCMC ### What does QLogixCMC do? QLogixCMC is a CMC and GMP compliance consulting firm for regulated life sciences manufacturers. Its consultants and engineers work on the client's premises or remotely, depending on the scope of work and the deliverables: CMC strategy and regulatory submissions from IND to NDA and BLA, pharmaceutical quality systems, validation of systems, equipment and processes, deviation investigations and CAPA backlogs, FDA inspection readiness, agency responses and compliance remediation, implementation and administration of GxP systems, and AI in the quality system under governance. Every GxP decision stays with the client's qualified people. ### What is CMC consulting? CMC consulting is specialist support for the chemistry, manufacturing and controls part of drug development and regulatory submissions: the control strategy, the specifications, the stability program, the manufacturing process description and the CTD Module 3 documents, together with the GMP quality systems, validation and inspection readiness that support them. QLogixCMC provides it to biotech, pharma, CDMO and 503B clients from the first IND through commercial supply and post-approval change. ### What does CMC stand for? CMC stands for chemistry, manufacturing and controls: the part of drug development and a regulatory submission that describes the drug substance and the drug product, how they are made, how they are tested and how their quality is controlled. QLogixCMC takes its name from that work and from the quality systems that surround it. ### Who is QLogixCMC for? QLogixCMC works with emerging and mid-size biotech and pharma companies building or scaling a quality system and a CMC program, CDMOs and CMOs running several client quality agreements, 503B outsourcing facilities meeting cGMP expectations with lean teams, and medical device and combination product manufacturers. ### Which product modalities does QLogixCMC cover? QLogixCMC covers small molecules, biologics such as monoclonal antibodies and recombinant proteins, sterile injectables, mRNA and other nucleic acid products, cell immunotherapies such as CAR-T, gene therapies including viral vector products, and drug-device combination products. The consultants on an engagement are chosen for the modality: an mRNA or cell therapy program gets people who have run those processes and released those batches. ### When should a company bring in a CMC consultant? Typically before a first IND or IMPD, when a submission timeline is at risk, ahead of an NDA, BLA or MAA, before a pre-approval inspection, after a Form 483 or a warning letter, or when a technology transfer, a new site or a post-approval change needs CMC and quality expertise the team does not have in-house. QLogixCMC starts with an assessment and a prioritized plan in each case. ### Services ### Which services does QLogixCMC offer? Seven practice areas, delivered on the client's premises or remotely as the scope of work and the deliverables require: CMC and regulatory (strategy, Module 3 authoring, control strategy, specifications and stability, post-approval changes and technology transfer); quality systems and QMS (gap assessment, design, SOPs, remediation and digitization); validation and computer software assurance; investigations, CAPA and backlog remediation; inspection readiness and compliance remediation, with audits and 483 and warning letter responses; GxP systems implementation and administration; and AI and digital quality. They are delivered separately or as one program. ### Do we have to replace our QMS or other systems? No. QLogixCMC starts from the processes, systems and records a site already has. Where the fix is procedural, the work is procedural. Where a system is holding the site back, QLogixCMC helps select, implement and validate a new one; the advice does not depend on the vendor. ### Can you take on a backlog of open investigations and CAPAs? Yes. QLogixCMC triages every open record by risk and age, agrees the standard for a closed record with the quality unit, and works the queue in risk order with a weekly burn-down, while coaching the site's investigators on live records so the backlog stays closed. ### Do your consultants work on site or remotely? Both, depending on the scope of work and the deliverables. System go-lives, validation execution, technology transfers and inspections put QLogixCMC engineers on the client's premises, full-time or part-time, for a project or a season. Submission authoring, reviews, assessments and system administration can run remotely, in the client's systems and under its procedures. The engagement letter says which applies to each deliverable. ### Can you administer our eQMS, LIMS or MES for us? Yes. Under a written service description, QLogixCMC engineers hold the system administrator role for the quality, laboratory or manufacturing systems a site runs: users and roles, releases, configuration changes through change control, audit trail and periodic review, monitoring and first-line support, on site or on a schedule. ### Do you provide interim quality or regulatory leadership? Yes. Where a site has no head of quality, qualified person or CMC regulatory lead yet, a QLogixCMC consultant can hold the role on an interim basis, with the authority and the accountability written into the engagement, until the site hires one. ### Compliance ### Which regulations and frameworks does QLogixCMC work to? QLogixCMC works to 21 CFR Parts 210 and 211, 21 CFR Part 820 (QMSR), 21 CFR Part 11, EU GMP Parts I and II with Annexes 11, 15 and the draft Annex 22 on AI, ICH Q1A(R2), Q6A/Q6B, Q8 to Q12 and M4Q, GAMP 5 (Second Edition), FDA's computer software assurance and process validation guidance, and PIC/S PI 041 on data integrity, with ALCOA+ throughout. ### How do you keep AI in a decision-support role? Every AI function QLogixCMC designs or validates has a defined intended use, a risk assessment, a workflow in which its output is a draft that a named person reviews, change control for the model and the prompts, and monitoring in use. AI contributions are labelled, quote the evidence they used and are recorded in the audit trail. Classification, root cause, batch disposition and every other GxP decision stay with qualified people. ### Working with QLogixCMC ### How does an engagement start? Most QLogixCMC engagements start with an assessment: of the CMC program, the quality system, the validation state, the backlog or the inspection readiness, depending on what is on the client's mind. It ends with a prioritized plan and baseline measures agreed before anything changes, so the improvement can be shown. ### Where does QLogixCMC work? QLogixCMC is based in Newport Beach, California. Its consultants and engineers work on clients' premises across the United States and remotely, depending on the scope of work and the deliverables. ### How are engagements priced? By fixed scope and price where the deliverable is defined, such as a CMC gap assessment, a mock inspection or a Module 3 section; by time and materials for engineers deployed on site, a backlog remediation or interim leadership; and by a monthly fee for ongoing system administration. QLogixCMC proposes the model that fits after the first conversation. ## Talk it through with someone who has run a plant Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone. [Request a meeting](https://qlogixcmc.com/contact)[Email us](mailto:contact@qlogixcmc.com) In the first meeting we cover - What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working - What we would assess first, and what we would leave alone - Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start --- # CMC and GMP consulting services for life sciences | QLogixCMC Source: https://qlogixcmc.com/services # CMC consulting services for biotech, pharma, CDMOs and 503B facilities QLogixCMC works in seven practice areas, on your premises or remotely depending on the scope of work and the deliverables, separately or as one program. Each starts from the processes, systems and records you already have, and keeps every GxP decision with your qualified people. - [01CMC and regulatoryCMC consulting is the chemistry, manufacturing and controls work behind a regulatory submission: the control strategy, the specifications, the stability program, the manufacturing process description and the documents in Module 3 of the Common Technical Document. QLogixCMC plans that work for small molecules, biologics, sterile injectables, mRNA, cell immunotherapies and gene therapies, writes and reviews the documents from IND and IMPD through NDA, BLA and MAA, and supports the site through agency questions, post-approval changes and technology transfers.Read about CMC and regulatory](https://qlogixcmc.com/services/cmc-and-regulatory) - [02Quality systems and QMSQuality systems consulting is the design, repair and digitization of a pharmaceutical quality system so that it meets 21 CFR Parts 210/211, Part 820 and ICH Q10 and fits the way the site runs. QLogixCMC assesses the system you have, designs or remediates the processes and procedures, and, where you choose, moves them onto a validated electronic QMS.Read about quality systems and QMS](https://qlogixcmc.com/services/quality-systems) - [03Validation and computer software assuranceValidation is the documented evidence that a system, a piece of equipment or a process does what it is intended to do, consistently. QLogixCMC plans and runs validation that is scaled to risk: computer software assurance for computerized systems, qualification of equipment and utilities, and process validation across its three stages, with the evidence written so an inspector can follow it.Read about validation and computer software assurance](https://qlogixcmc.com/services/validation-and-csa) - [04Investigations, CAPA and backlog remediationAn investigation is the written, evidence-based account of what went wrong, why, what it affected and what will stop it recurring. QLogixCMC investigates deviations, out-of-specification results and complaints with your team, concludes root causes the evidence supports, writes CAPAs that can be checked for effectiveness, and clears aged backlogs to the same standard.Read about investigations, CAPA and backlog remediation](https://qlogixcmc.com/services/investigations-and-capa) - [05Inspection readiness and compliance remediationInspection readiness is the state in which a site can show an inspector, on request and from its own records, that it operates in control; compliance remediation is the program that gets a site back to that state after an observation, a warning letter or its own audit. QLogixCMC runs mock inspections and audits that find what an inspector would, prepares the site and its people, writes responses to FDA Form 483 observations and warning letters, and plans and manages the remediation to closure.Read about inspection readiness and compliance remediation](https://qlogixcmc.com/services/inspection-readiness) - [06GxP systems implementation and administrationGxP systems implementation is the service in which QLogixCMC engineers, on your premises or remotely as the scope requires, bring the quality, laboratory or manufacturing system you have chosen live and then run it for you: implementation, configuration to your SOPs, migration of the records you keep, risk-based validation, and ongoing system administration with the users, roles, releases, periodic reviews and support a validated system needs.Read about gxP systems implementation and administration](https://qlogixcmc.com/services/gxp-systems-implementation) - [07AI and digital qualityAI and digital quality consulting is the work of bringing AI into a regulated quality system without losing control of it: choosing the use cases by risk, setting the governance, connecting the data the AI needs, designing workflows in which AI drafts and people decide, and validating the result. QLogixCMC does that work on the systems a site already runs or on the platform it chooses.Read about AI and digital quality](https://qlogixcmc.com/services/ai-and-digital-quality) ## Talk it through with someone who has run a plant Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone. [Request a meeting](https://qlogixcmc.com/contact)[Email us](mailto:contact@qlogixcmc.com) In the first meeting we cover - What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working - What we would assess first, and what we would leave alone - Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start --- # CMC regulatory consulting: IND to NDA and BLA | QLogixCMC Source: https://qlogixcmc.com/services/cmc-and-regulatory # CMC regulatory consulting: from IND to commercial supply CMC consulting is the chemistry, manufacturing and controls work behind a regulatory submission: the control strategy, the specifications, the stability program, the manufacturing process description and the documents in Module 3 of the Common Technical Document. QLogixCMC plans that work for small molecules, biologics, sterile injectables, mRNA, cell immunotherapies and gene therapies, writes and reviews the documents from IND and IMPD through NDA, BLA and MAA, and supports the site through agency questions, post-approval changes and technology transfers. [Request a meeting](https://qlogixcmc.com/contact)[All services](https://qlogixcmc.com/services) ## What we deliver - CMC development strategy and the plan of studies for each phase - Module 3 (CTD) authoring and review for IND, IMPD, NDA, BLA and MAA submissions - Control strategy, critical quality attributes and critical process parameters - Specifications, analytical method validation plans and stability protocols to ICH Q1A(R2) - Process description, process validation strategy and comparability protocols - Post-approval changes: classification, reporting category and supporting data - Technology transfer packages and receiving-site readiness - Preparation for pre-IND, end-of-phase and pre-approval meetings ## How the work runs We begin with a CMC gap assessment of the development history, the data on hand and the target submission, and produce a plan that says which studies, documents and decisions are on the critical path. Writing starts from the data and the batch records, not from a template, so the narrative in Module 3 matches the evidence behind it. Every document is reviewed against the ICH guideline it answers to and the agency's questions on similar products. For technology transfers, we run the gap analysis between sending and receiving sites, write the transfer protocol, and stay with the receiving site through the first batches. ## What makes it hold up under review - Control strategy built on ICH Q8, Q9(R1), Q10 and Q11 principles, with the risk assessments on file - Specifications justified to ICH Q6A and Q6B from the batch data and the clinical exposure - Stability data presented to ICH Q1A(R2) and Q1E, with shelf-life proposals the data supports - Post-approval changes classified under ICH Q12 and the applicable FDA and EMA guidance - Every statement in the submission traceable to a report, a batch record or a validated method ## Your qualified people decide - The sponsor's regulatory lead owns the submission strategy and signs off every document that goes to an agency. - Specifications, shelf life and change classifications are proposed by us and decided by your qualified people. ## Frameworks this work is built to - ICH M4Q (CTD) - ICH Q1A(R2) - ICH Q6A / Q6B - ICH Q8 / Q11 - ICH Q9(R1) - ICH Q12 - 21 CFR Parts 210/211 - EU GMP Part I ## Included - CMC strategy - Module 3 authoring - Control strategy - Specifications and stability - Post-approval changes - Technology transfer ## Questions about CMC and regulatory ### What does a CMC consultant do? A CMC consultant plans and documents how a drug substance and a drug product are made, tested and controlled so that a regulatory submission can be approved and the product can be made consistently. At QLogixCMC that means the CMC development strategy, the control strategy, specifications and stability, the Module 3 sections of the CTD, agency meeting preparation, post-approval changes and technology transfers, drafted with the sponsor's team and decided by its qualified people. ### When should a biotech bring in CMC consulting? Before the first IND or IMPD, when the CMC package is being built; before an end-of-phase meeting, when the control strategy and the validation plan are set; in the year before an NDA, BLA or MAA, when Module 3 is written and the pre-approval inspection is prepared; and whenever a technology transfer, a post-approval change or an agency question needs CMC expertise the team does not have. QLogixCMC starts each with a CMC gap assessment. ### Which products do you cover? QLogixCMC works on small molecules, biologics, sterile injectables, mRNA and other nucleic acid products, cell immunotherapies such as CAR-T, gene therapies and drug-device combination products, for both drug substance and drug product. The team is assembled for the product: a biologics submission gets consultants who have run biologics processes, and an advanced therapy gets people who have released vector, cell and mRNA batches. ### Do you support mRNA, cell therapy and gene therapy CMC? Yes. For mRNA, QLogixCMC covers the plasmid DNA template, in vitro transcription, lipid nanoparticle formulation, the identity, integrity, purity and potency specifications and the stability program. For cell immunotherapies, the apheresis starting material, the vector, the manufacturing process, release testing with a potency assay, chain of identity and custody, and the vein-to-vein timeline. For gene therapies, the plasmid and vector production, capsid and genome characterization, specifications and comparability through process changes. Submissions follow the FDA CBER and EMA ATMP guidance that applies. ### Can you write Module 3 from our data? Yes. QLogixCMC authors Module 3 sections from your development reports, batch records, analytical data and stability tables, and reviews sections your team has written. Each statement is traced to the document that supports it, so the submission can be defended in an agency question. ### Do you support post-approval changes? Yes. QLogixCMC classifies the change under ICH Q12 and the FDA or EMA guidance that applies, defines the supporting studies, writes the variation or supplement, and tracks the commitments to closure. ### How do you work with our regulatory affairs team? As part of it. QLogixCMC drafts, reviews and advises; your regulatory lead owns the strategy and every document that goes to an agency. Where you have no regulatory function yet, we can act as the CMC regulatory lead until you hire one. ## Related services - [Quality systems and QMSA pharmaceutical quality system designed for how your site actually runs: gap assessment, procedures, remediation, and the move from paper or a legacy QMS to a validated electronic one.](https://qlogixcmc.com/services/quality-systems) - [Validation and computer software assuranceRisk-based validation of computerized systems, equipment and processes, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, documented for inspection.](https://qlogixcmc.com/services/validation-and-csa) - [Investigations, CAPA and backlog remediationDeviation, OOS and complaint investigations that reach a defensible root cause, CAPAs that are checked for effectiveness, and aged backlogs cleared without lowering the standard.](https://qlogixcmc.com/services/investigations-and-capa) - [Inspection readiness and compliance remediationFDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure.](https://qlogixcmc.com/services/inspection-readiness) - [GxP systems implementation and administrationEngineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day.](https://qlogixcmc.com/services/gxp-systems-implementation) - [AI and digital qualityAI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide.](https://qlogixcmc.com/services/ai-and-digital-quality) ## Talk it through with someone who has run a plant Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone. [Request a meeting](https://qlogixcmc.com/contact)[Email us](mailto:contact@qlogixcmc.com) In the first meeting we cover - What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working - What we would assess first, and what we would leave alone - Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start --- # Pharmaceutical quality system and QMS consulting | QLogixCMC Source: https://qlogixcmc.com/services/quality-systems # Quality systems and QMS consulting for life sciences Quality systems consulting is the design, repair and digitization of a pharmaceutical quality system so that it meets 21 CFR Parts 210/211, Part 820 and ICH Q10 and fits the way the site runs. QLogixCMC assesses the system you have, designs or remediates the processes and procedures, and, where you choose, moves them onto a validated electronic QMS. [Request a meeting](https://qlogixcmc.com/contact)[All services](https://qlogixcmc.com/services) ## What we assess and design The core quality processes, written as connected workflows rather than separate forms, so a deviation can open a CAPA, a CAPA can open a change control, and each record links back to the evidence behind it. - Deviations and investigations - CAPA, with effectiveness checks - Change control - Complaints and recalls - Document control and training - Supplier qualification and quality agreements - Management review and quality metrics - Annual product review (APR/PQR) ## How the work runs We start with a gap assessment against the regulations that apply to your products and the procedures you already have, and agree baseline measures such as deviation cycle time and backlog age before anything changes. The assessment decides the order of work: which processes are rewritten first, which need remediation, and which records have to be migrated. Procedures are drafted with the people who will follow them, piloted on live records, and released through your document control with the training that goes with them. Where the site moves to an electronic QMS, selection, configuration, data migration and validation run together with the SOP updates, so the system goes live with procedures that describe how it is used. ## Electronic QMS: the one you choose Where a site moves to an electronic QMS, we help select the product against your requirements, then configure, migrate to and validate it. The advice does not depend on the vendor: the recommendation follows your processes, your records and your budget, and the same engineers implement whichever eQMS the site chooses. - Requirements and selection, with a scored comparison of the candidates - Configuration to your SOPs, not the vendor's template - Migration of the records you have to keep, verified against the source - Risk-based validation following GAMP 5 (Second Edition) ## Your qualified people decide - The quality unit approves every procedure, the rollout plan and the configuration decisions. - Dispositions, approvals and signatures stay with the named, qualified people in your procedures. ## Frameworks this work is built to - 21 CFR Parts 210/211 - 21 CFR Part 820 (QMSR) - 21 CFR Part 11 - EU GMP Chapter 1 - EU GMP Annex 11 - ICH Q10 - ISO 13485 ## Included - Gap assessment - QMS design and SOPs - Remediation - eQMS selection - Implementation and migration - Training ## Questions about quality systems and QMS ### Do we have to replace our current QMS? Not necessarily. QLogixCMC starts with a gap assessment of the processes and the system you have. Where the procedures are the problem, the fix is procedural. Where the system itself is holding the site back, we help you select, implement and validate an electronic QMS that fits your processes and your budget. ### How long does a gap assessment take? A gap assessment of a single site's quality system usually takes two to four weeks of QLogixCMC time, depending on the number of processes in scope and how much of the documentation is available before the site visit. It ends with a prioritized remediation plan and agreed baseline measures. ### Can you write our SOPs? Yes. QLogixCMC drafts procedures with the people who will follow them, so they describe the process as it will actually run. Your quality unit reviews and approves every procedure before it is released through your document control. ### Who is this service for? Emerging and mid-size biotech and pharma companies building a quality system ahead of clinical or commercial manufacturing, CDMOs and CMOs aligning one system to several client quality agreements, 503B outsourcing facilities meeting cGMP expectations with lean teams, and medical device manufacturers moving to the Quality Management System Regulation (QMSR). ## Related services - [CMC and regulatoryChemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies.](https://qlogixcmc.com/services/cmc-and-regulatory) - [Validation and computer software assuranceRisk-based validation of computerized systems, equipment and processes, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, documented for inspection.](https://qlogixcmc.com/services/validation-and-csa) - [Investigations, CAPA and backlog remediationDeviation, OOS and complaint investigations that reach a defensible root cause, CAPAs that are checked for effectiveness, and aged backlogs cleared without lowering the standard.](https://qlogixcmc.com/services/investigations-and-capa) - [Inspection readiness and compliance remediationFDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure.](https://qlogixcmc.com/services/inspection-readiness) - [GxP systems implementation and administrationEngineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day.](https://qlogixcmc.com/services/gxp-systems-implementation) - [AI and digital qualityAI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide.](https://qlogixcmc.com/services/ai-and-digital-quality) ## Talk it through with someone who has run a plant Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone. [Request a meeting](https://qlogixcmc.com/contact)[Email us](mailto:contact@qlogixcmc.com) In the first meeting we cover - What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working - What we would assess first, and what we would leave alone - Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start --- # Validation, CSV and computer software assurance (CSA) | QLogixCMC Source: https://qlogixcmc.com/services/validation-and-csa # Validation and computer software assurance Validation is the documented evidence that a system, a piece of equipment or a process does what it is intended to do, consistently. QLogixCMC plans and runs validation that is scaled to risk: computer software assurance for computerized systems, qualification of equipment and utilities, and process validation across its three stages, with the evidence written so an inspector can follow it. [Request a meeting](https://qlogixcmc.com/contact)[All services](https://qlogixcmc.com/services) ## What we validate - Computerized systems: QMS, LIMS, MES, ERP, CMMS, document management and laboratory instruments - AI-enabled and agentic systems: intended use, risk assessment, test evidence and monitoring in use - Equipment and utilities: design, installation, operational and performance qualification - Processes: process design, process performance qualification and continued process verification - Cleaning validation and analytical method validation support - Data integrity controls and audit trail review procedures ## How the work runs A validation master plan sets the approach, the risk model and the deliverables for the site or the program. Each system or process then gets a risk assessment that decides how much testing it needs: a high-risk function that affects product quality or patient safety is scripted and witnessed; a low-risk one is covered by unscripted or ad hoc testing with the result recorded, as FDA's computer software assurance guidance allows. Protocols are written from the user requirements and the risk assessment, executed with the people who will run the system, and reported with every deviation resolved. Supplier assessments and vendor documentation are used where they are adequate, so testing is not repeated for its own sake. ## Validating AI-enabled systems AI functions in a GxP system are validated by defining the intended use, assessing the risk of a wrong output, testing against acceptance criteria on a representative set of records, keeping the model and the prompts under change control and monitoring performance in use. Human review of the output is a control in the risk assessment, not a reason to skip validation. - Intended use and the boundary of what the AI may and may not do - Risk assessment of wrong, missing or misleading output - Test sets with known answers, acceptance criteria and the evidence of the run - Change control for model, prompt and configuration updates - Periodic review against the baseline performance ## Your qualified people decide - Your validation lead or quality unit approves the master plan, each risk assessment and each report. - Release of a system, a piece of equipment or a process for GMP use is a decision of your qualified people. ## Frameworks this work is built to - GAMP 5 (2nd ed.) - FDA CSA guidance - 21 CFR Part 11 - EU GMP Annex 11 - EU GMP Annex 15 - FDA Process Validation guidance - ICH Q9(R1) - EU GMP Annex 22 (draft) ## Included - Validation master plans - CSV and CSA - Equipment qualification - Process validation - AI-enabled systems - Periodic review ## Questions about validation and computer software assurance ### What is computer software assurance? Computer software assurance (CSA) is FDA's risk-based approach to establishing confidence in software used in production and the quality system. Testing effort follows the risk of the function: high-risk functions get scripted, documented testing; lower-risk functions get unscripted or ad hoc testing with the result recorded. It replaces the uniform, document-heavy approach of traditional CSV. ### Do you accept vendor validation packages? Where they are adequate, yes. QLogixCMC assesses the supplier and the package against your intended use and risk assessment, uses what covers your use, and tests only what the package does not cover or what is configured for your site. ### Can AI functions be validated at all? Yes. QLogixCMC validates AI functions by defining the intended use, assessing the risk of wrong output, testing against acceptance criteria on records with known answers, placing the model and prompts under change control and monitoring performance in use. The draft EU GMP Annex 22 sets out the same expectations. ### How is validation documented for an inspection? With a validation master plan, a risk assessment per system or process, user requirements, protocols with executed evidence, deviation records and a summary report that states whether the system is fit for its intended use. Every document is approved by your quality unit before the system is released. ## Related services - [CMC and regulatoryChemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies.](https://qlogixcmc.com/services/cmc-and-regulatory) - [Quality systems and QMSA pharmaceutical quality system designed for how your site actually runs: gap assessment, procedures, remediation, and the move from paper or a legacy QMS to a validated electronic one.](https://qlogixcmc.com/services/quality-systems) - [Investigations, CAPA and backlog remediationDeviation, OOS and complaint investigations that reach a defensible root cause, CAPAs that are checked for effectiveness, and aged backlogs cleared without lowering the standard.](https://qlogixcmc.com/services/investigations-and-capa) - [Inspection readiness and compliance remediationFDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure.](https://qlogixcmc.com/services/inspection-readiness) - [GxP systems implementation and administrationEngineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day.](https://qlogixcmc.com/services/gxp-systems-implementation) - [AI and digital qualityAI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide.](https://qlogixcmc.com/services/ai-and-digital-quality) ## Talk it through with someone who has run a plant Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone. [Request a meeting](https://qlogixcmc.com/contact)[Email us](mailto:contact@qlogixcmc.com) In the first meeting we cover - What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working - What we would assess first, and what we would leave alone - Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start --- # Deviation investigation and CAPA consulting | QLogixCMC Source: https://qlogixcmc.com/services/investigations-and-capa # Investigations, CAPA and backlog remediation An investigation is the written, evidence-based account of what went wrong, why, what it affected and what will stop it recurring. QLogixCMC investigates deviations, out-of-specification results and complaints with your team, concludes root causes the evidence supports, writes CAPAs that can be checked for effectiveness, and clears aged backlogs to the same standard. [Request a meeting](https://qlogixcmc.com/contact)[All services](https://qlogixcmc.com/services) ## What we do - Deviation investigations: problem statement, scope, impact, root cause and CAPA - OOS and OOT investigations to the FDA guidance: laboratory phase, then full-scale - Complaint investigations and reportability assessments - Root cause analysis: IS / IS NOT, fishbone, 5-Whys, fault tree and hypothesis testing - CAPA plans with owners, timing and defined effectiveness checks - Backlog remediation: triage by risk, standard work, and a weekly burn-down to closure - Investigator training and coaching on live records ## How the work runs Every investigation starts with a problem statement in IS / IS NOT form, from the initial report and the records around it: the batch record pages, the lab data, the equipment history, the procedure in force and the earlier events that look alike. Root cause candidates are tested against that evidence, and the conclusion names the evidence that supports it and the candidates that were ruled out. For a backlog, we triage every open record by product impact and age, agree a standard for what a closed record looks like, and work the queue in risk order with a weekly burn-down your quality unit can see. The goal is a backlog that stays closed, so recurring causes get one CAPA, not twenty. ## What makes it hold up in an inspection 21 CFR 211.192 requires unexplained discrepancies to be thoroughly investigated, with the conclusions and follow-up recorded. An inspector reads the investigation for the evidence, the reasoning and the timeliness. - Scope and impact assessed on every batch, product and system the event could have touched - Root cause stated with the evidence, not as "human error" by default - CAPA tied to the root cause, with an effectiveness check that can fail - Timeliness: investigations completed within the procedure's limit, or the extension justified - Trending across investigations, so a recurrence is seen before the next batch ## Your qualified people decide - Classification, product impact and reportability are decided by your qualified people. - Root cause is concluded with the investigator and approved by your quality unit. - CAPA actions are accepted or rejected one by one, and every record is signed by a person. ## Frameworks this work is built to - 21 CFR 211.192 - 21 CFR 211.198 - 21 CFR 820.100 - FDA OOS guidance - EU GMP Chapter 8 - ICH Q9(R1) - ICH Q10 ## Included - Deviation investigations - Root cause analysis - CAPA and effectiveness checks - OOS and OOT - Complaints - Backlog remediation ## Questions about investigations, CAPA and backlog remediation ### How quickly can you take on a backlog? QLogixCMC can start a backlog remediation within two weeks of the first call: the first week is triage of every open record by risk and age, the second sets the standard work and the burn-down. Records are closed in risk order, and your quality unit sees the queue every week. ### Do you write the investigations or coach our people? Both, and the mix is agreed at the start. QLogixCMC investigators write investigations with your team on live records and coach them as they go, so the site's own capability improves while the backlog comes down. ### Can AI help with investigations? Yes, in a decision-support role. Where a site's systems can draft the problem statement, list similar past events and propose root cause candidates from the records, quoting the evidence, QLogixCMC uses that output as a draft, and the investigator and the quality unit still review, edit, conclude and sign. ### What counts as a defensible root cause? One that the evidence supports, that explains the event as it happened, that rules out the alternatives considered, and that leads to a CAPA whose effectiveness can be checked. "Human error" is a symptom until the investigation shows why the error was possible. ## Related services - [CMC and regulatoryChemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies.](https://qlogixcmc.com/services/cmc-and-regulatory) - [Quality systems and QMSA pharmaceutical quality system designed for how your site actually runs: gap assessment, procedures, remediation, and the move from paper or a legacy QMS to a validated electronic one.](https://qlogixcmc.com/services/quality-systems) - [Validation and computer software assuranceRisk-based validation of computerized systems, equipment and processes, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, documented for inspection.](https://qlogixcmc.com/services/validation-and-csa) - [Inspection readiness and compliance remediationFDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure.](https://qlogixcmc.com/services/inspection-readiness) - [GxP systems implementation and administrationEngineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day.](https://qlogixcmc.com/services/gxp-systems-implementation) - [AI and digital qualityAI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide.](https://qlogixcmc.com/services/ai-and-digital-quality) ## Talk it through with someone who has run a plant Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone. [Request a meeting](https://qlogixcmc.com/contact)[Email us](mailto:contact@qlogixcmc.com) In the first meeting we cover - What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working - What we would assess first, and what we would leave alone - Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start --- # FDA inspection readiness and 483 response consulting | QLogixCMC Source: https://qlogixcmc.com/services/inspection-readiness # Quality inspection readiness and compliance remediation Inspection readiness is the state in which a site can show an inspector, on request and from its own records, that it operates in control; compliance remediation is the program that gets a site back to that state after an observation, a warning letter or its own audit. QLogixCMC runs mock inspections and audits that find what an inspector would, prepares the site and its people, writes responses to FDA Form 483 observations and warning letters, and plans and manages the remediation to closure. [Request a meeting](https://qlogixcmc.com/contact)[All services](https://qlogixcmc.com/services) ## What we do - Mock FDA, EMA and MHRA inspections, including pre-approval inspection readiness - Internal audits against your procedures and the applicable regulations - Supplier and contract manufacturer audits, with quality agreement review - Data integrity audits of laboratory and manufacturing systems - Inspection management: front room, back room, document retrieval and subject matter expert preparation - Responses to Form 483 observations, warning letters and EU non-compliance statements - Compliance remediation programs: root causes behind the findings, a prioritized plan, standard work and commitments tracked to closure - Data integrity remediation: access, audit trails, review practices and the procedures around them - Independent verification that the remediation holds, before the agency comes back ## How the work runs A mock inspection follows the inspector's path, not the site's org chart: the systems approach for an FDA inspection, the product and process for a pre-approval inspection, the data for a data integrity inspection. Findings are graded the way an agency would grade them, and the report says what the inspector would have written. Before the inspection, we prepare the subject matter experts on how to answer, rehearse the document retrieval and set up the back room. During it, we support the team. After a Form 483 or a warning letter, we write the response with the site, with corrective actions that answer the observation, and dates the site can keep, and we track every commitment until it is closed. ## How a remediation program runs A remediation program starts from the findings, yours or the agency's, and the systemic causes behind them: a procedure that does not match practice, a system without audit trail review, a quality unit without the authority or the headcount the regulations assume. The plan fixes the causes in risk order, with an owner, a date and the evidence each action will leave behind, and a weekly review the site leadership and the quality unit can see. Engineers on your premises carry the actions that need the floor: procedure rewrites with the people who follow them, retraining, system fixes and their validation. Remote work covers document review, response drafting and tracking. Each commitment closes with an effectiveness check, so the remediation holds when the agency returns. ## What a good response contains - An understanding of each observation, including the systemic cause behind it - Corrections already made, with evidence, and corrective actions with dates - A review of whether the same issue exists elsewhere on the site or in other products - An effectiveness check for each action, so the agency can see it will hold - Progress updates on the schedule the response promises ## Your qualified people decide - Site leadership and the quality unit own every response to an agency and every commitment in it. - Audit findings are classified by us and accepted, disputed or re-graded by your qualified people. ## Frameworks this work is built to - 21 CFR Parts 210/211 - 21 CFR Part 820 (QMSR) - 21 CFR Part 11 - EU GMP Chapter 9 - FDA Compliance Program 7356.002 - PIC/S PI 041 (data integrity) - ICH Q10 ## Included - Mock inspections - Inspection management - Internal and supplier audits - 483 and warning letter responses - Compliance remediation programs - Data integrity remediation ## Questions about inspection readiness and compliance remediation ### How far ahead of an inspection should a mock inspection run? Two to three months before an expected inspection, so there is time to fix what it finds. For a pre-approval inspection, QLogixCMC starts the readiness work when the submission is filed. A mock inspection the week before an inspection finds problems that can no longer be fixed. ### Do you respond to a Form 483 within 15 business days? Yes. QLogixCMC can join the site the day the Form 483 is issued and write the response with the team inside FDA's 15-business-day window, with corrections already made where possible and corrective actions with dates the site can keep. ### Can you audit our suppliers and contract manufacturers? Yes. QLogixCMC auditors audit suppliers, CDMOs and contract laboratories against your quality agreement and the regulations that apply, on site or remotely, and write reports your supplier qualification program can act on. ### What does a compliance remediation program involve? QLogixCMC starts from the findings and the systemic causes behind them, writes a prioritized plan with an owner, a date and the evidence each action will leave, and runs a weekly review with site leadership and the quality unit. Engineers carry the actions that need the floor, such as procedure rewrites, retraining and system fixes with their validation; document review, response drafting and tracking can run remotely. Every commitment closes with an effectiveness check. ### What is a data integrity audit? A review of whether the records a site relies on are attributable, legible, contemporaneous, original and accurate (ALCOA+), across laboratory instruments, manufacturing systems and paper records: user access, audit trails, review of audit trails, backup and retention, and the practices around them. ## Related services - [CMC and regulatoryChemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies.](https://qlogixcmc.com/services/cmc-and-regulatory) - [Quality systems and QMSA pharmaceutical quality system designed for how your site actually runs: gap assessment, procedures, remediation, and the move from paper or a legacy QMS to a validated electronic one.](https://qlogixcmc.com/services/quality-systems) - [Validation and computer software assuranceRisk-based validation of computerized systems, equipment and processes, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, documented for inspection.](https://qlogixcmc.com/services/validation-and-csa) - [Investigations, CAPA and backlog remediationDeviation, OOS and complaint investigations that reach a defensible root cause, CAPAs that are checked for effectiveness, and aged backlogs cleared without lowering the standard.](https://qlogixcmc.com/services/investigations-and-capa) - [GxP systems implementation and administrationEngineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day.](https://qlogixcmc.com/services/gxp-systems-implementation) - [AI and digital qualityAI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide.](https://qlogixcmc.com/services/ai-and-digital-quality) ## Talk it through with someone who has run a plant Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone. [Request a meeting](https://qlogixcmc.com/contact)[Email us](mailto:contact@qlogixcmc.com) In the first meeting we cover - What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working - What we would assess first, and what we would leave alone - Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start --- # eQMS, LIMS and MES implementation and administration | QLogixCMC Source: https://qlogixcmc.com/services/gxp-systems-implementation # GxP systems implementation and administration, on site or remote GxP systems implementation is the service in which QLogixCMC engineers, on your premises or remotely as the scope requires, bring the quality, laboratory or manufacturing system you have chosen live and then run it for you: implementation, configuration to your SOPs, migration of the records you keep, risk-based validation, and ongoing system administration with the users, roles, releases, periodic reviews and support a validated system needs. [Request a meeting](https://qlogixcmc.com/contact)[All services](https://qlogixcmc.com/services) ## What the implementation covers An eQMS, LIMS, MES, CMMS or document management system goes live in the order the assessment set, configured to your procedures rather than the vendor's template, and connected to the systems you keep. - Workspace set-up: sites, organizations, roles, access levels and numbering - Configuration of each module to your procedures: deviations, CAPA, change control, complaints, documents, training, samples and results, batch records, equipment and the rest - Migration of legacy records and documents, verified against the source - Integration with the QMS, LIMS, MES or ERP you keep, through the vendors' interfaces - Risk-based validation following GAMP 5 (Second Edition) and computer software assurance, with the evidence on file - SOP updates, training and go-live support on the floor ## What administration covers A validated system needs an administrator who understands both the system and the regulations. Where you do not want to staff that role, our engineers hold it, on site or on a schedule, under a written service description. - User and role administration, access reviews and site restrictions - Release management: assessing each vendor release, regression testing and change control - Configuration changes through your change control, with the validation impact assessed - Audit trail review procedures and periodic system review - Monitoring of integrations, data feeds and scheduled jobs - First-line support for your users and the escalation path to the vendor ## On your premises or remote The scope of work and the deliverables decide where the engineers sit, and the engagement letter says which. - On the floor: configuration workshops with the people who run the process, validation execution with your users, go-live support and inspections - Remote: configuration build, migration scripts, protocol authoring, release assessments and day-to-day administration - Go-live problems are fixed the same day, in person where it matters - The administrator knows your site, your products and your inspectors either way ## Your qualified people decide - Your quality unit approves the configuration, the validation and the release of the system for GMP use. - Every record in the system is reviewed, approved and signed by your qualified people; the administrator never signs on their behalf. ## Frameworks this work is built to - 21 CFR Part 11 - EU GMP Annex 11 - GAMP 5 (2nd ed.) - FDA CSA guidance - 21 CFR Parts 210/211 - ICH Q10 ## Included - Implementation and configuration - Data migration - Validation - System administration - Release management - User training and support ## Questions about gxP systems implementation and administration ### Do we need our own system administrator? Not if you do not want one. QLogixCMC engineers administer your eQMS, LIMS or MES for you under a written service description: users and roles, releases, configuration changes through your change control, periodic review and support. Many sites start that way and take the role in-house once their team is ready. ### How long does an implementation take? It depends on the modules in scope and the records to migrate. A single site implementing the core quality modules with QLogixCMC engineers on the premises typically goes live in stages over a few months, with the first module, usually deviations and CAPA, validated and in use first. ### Is the system validated when you implement it? Most vendors supply validation documentation for the product itself. QLogixCMC assesses that package, validates your configuration and your intended use on top of it, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, and your quality unit approves the release for GMP use. ### Which systems do you implement? QLogixCMC works with the eQMS, LIMS, MES, CMMS and document management products its clients choose, and helps with the selection where the choice is still open; see quality systems and QMS, and validation and computer software assurance. ## Related services - [CMC and regulatoryChemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies.](https://qlogixcmc.com/services/cmc-and-regulatory) - [Quality systems and QMSA pharmaceutical quality system designed for how your site actually runs: gap assessment, procedures, remediation, and the move from paper or a legacy QMS to a validated electronic one.](https://qlogixcmc.com/services/quality-systems) - [Validation and computer software assuranceRisk-based validation of computerized systems, equipment and processes, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, documented for inspection.](https://qlogixcmc.com/services/validation-and-csa) - [Investigations, CAPA and backlog remediationDeviation, OOS and complaint investigations that reach a defensible root cause, CAPAs that are checked for effectiveness, and aged backlogs cleared without lowering the standard.](https://qlogixcmc.com/services/investigations-and-capa) - [Inspection readiness and compliance remediationFDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure.](https://qlogixcmc.com/services/inspection-readiness) - [AI and digital qualityAI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide.](https://qlogixcmc.com/services/ai-and-digital-quality) ## Talk it through with someone who has run a plant Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone. [Request a meeting](https://qlogixcmc.com/contact)[Email us](mailto:contact@qlogixcmc.com) In the first meeting we cover - What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working - What we would assess first, and what we would leave alone - Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start --- # AI governance and validation for GxP quality systems | QLogixCMC Source: https://qlogixcmc.com/services/ai-and-digital-quality # AI and digital quality: adopting AI in a GxP quality system AI and digital quality consulting is the work of bringing AI into a regulated quality system without losing control of it: choosing the use cases by risk, setting the governance, connecting the data the AI needs, designing workflows in which AI drafts and people decide, and validating the result. QLogixCMC does that work on the systems a site already runs or on the platform it chooses. [Request a meeting](https://qlogixcmc.com/contact)[All services](https://qlogixcmc.com/services) ## What we do - AI readiness assessment: processes, data, systems and the regulatory position - Use-case selection by value and risk, with an intended use for each - AI governance: policy, roles, model and prompt change control, monitoring - Agentic workflow design: what the agent gathers, drafts and chases, and where a person decides - Connected quality data: linking QMS, LIMS, MES, ERP and batch records for trending and signals - Validation of AI-enabled systems to GAMP 5 and the draft EU GMP Annex 22 - Training for the quality unit and the investigators who will work with AI output ## How the work runs The readiness assessment maps the processes where time goes to gathering and drafting, the data those processes need and where it lives, and the controls the regulations expect. From it we select the first use cases: usually investigation drafting, backlog triage and trending, because the value is measurable and the risk is managed by review. Each use case gets an intended use, a risk assessment, a workflow in which the AI's output is a draft a named person reviews, and a validation plan. The work lands in the systems the site runs: we connect the QMS, LIMS, MES and ERP it keeps, or design the workflow around them, and the same controls apply whichever AI platform the site has chosen. The baseline measures from the assessment are tracked after go-live. ## The principles we hold to - AI is decision support: it drafts, summarizes, trends and flags; qualified people review, approve and sign - Every AI contribution is labelled, quotes the evidence it used and is recorded in the audit trail - Models, prompts and configuration are under change control - Access follows least privilege, and agents write drafts, not approved records - Performance is monitored in use and reviewed periodically against the baseline ## Your qualified people decide - The quality unit approves the intended use, the risk assessment and the workflow for every AI function. - Every GxP decision, from classification to batch disposition, stays with your qualified people, and AI output is a draft until one of them signs. ## Frameworks this work is built to - EU GMP Annex 22 (draft) - GAMP 5 (2nd ed.) - FDA CSA guidance - 21 CFR Part 11 - EU GMP Annex 11 - ICH Q9(R1) - ICH Q10 - ISO/IEC 42001 ## Included - AI governance - Use-case assessment - Agentic workflow design - Connected quality data - AI validation - Change control for models ## Questions about AI and digital quality ### Where should a quality team start with AI? With the work that takes the most time and carries the least decision risk: drafting investigations from the records, triaging a backlog by risk, and trending across deviations, complaints and lab results. QLogixCMC selects the first use cases in a readiness assessment and sets an intended use and a risk assessment for each. ### Is AI acceptable to regulators in a GxP quality system? Yes, in a decision-support role with the controls the regulations already expect: a defined intended use, validation scaled to risk, human review of the output, change control and an audit trail. The draft EU GMP Annex 22 sets those expectations out for AI in GMP, and FDA's computer software assurance guidance applies to the software. ### Do we have to buy a new platform to use AI in the quality system? No. The governance, the use-case selection, the workflow design and the validation QLogixCMC provides apply to whatever systems a site runs. Where a new AI or quality platform is justified, we help select and validate it; where it is not, we connect to the QMS, LIMS, MES or ERP you keep. ### What is an agentic workflow? A workflow in which an AI agent carries out a defined sequence of routine work across systems, such as gathering the records behind a deviation, drafting the problem statement and chasing the open actions, inside guardrails that limit what it may read and write, and hands every decision to a named person. ## Related services - [CMC and regulatoryChemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies.](https://qlogixcmc.com/services/cmc-and-regulatory) - [Quality systems and QMSA pharmaceutical quality system designed for how your site actually runs: gap assessment, procedures, remediation, and the move from paper or a legacy QMS to a validated electronic one.](https://qlogixcmc.com/services/quality-systems) - [Validation and computer software assuranceRisk-based validation of computerized systems, equipment and processes, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, documented for inspection.](https://qlogixcmc.com/services/validation-and-csa) - [Investigations, CAPA and backlog remediationDeviation, OOS and complaint investigations that reach a defensible root cause, CAPAs that are checked for effectiveness, and aged backlogs cleared without lowering the standard.](https://qlogixcmc.com/services/investigations-and-capa) - [Inspection readiness and compliance remediationFDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure.](https://qlogixcmc.com/services/inspection-readiness) - [GxP systems implementation and administrationEngineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day.](https://qlogixcmc.com/services/gxp-systems-implementation) ## Talk it through with someone who has run a plant Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone. [Request a meeting](https://qlogixcmc.com/contact)[Email us](mailto:contact@qlogixcmc.com) In the first meeting we cover - What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working - What we would assess first, and what we would leave alone - Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start --- # Request a meeting with a CMC consultant | QLogixCMC Source: https://qlogixcmc.com/contact # Request a meeting Tell us about your site and what is on your mind. We will reply to set up a time to talk. Name Work email Company Role (optional) What would you like to look at? Website Send request --- # Site map | QLogixCMC Source: https://qlogixcmc.com/sitemap # Site map Every public QLogixCMC page. Each page is also available as plain Markdown at its address plus “.md”, for AI assistants and readers that prefer text. ## Company - [QLogixCMC home](https://qlogixcmc.com/)[Markdown](https://qlogixcmc.com/index.md) - [Services](https://qlogixcmc.com/services)[Markdown](https://qlogixcmc.com/services.md) - [Request a meeting](https://qlogixcmc.com/contact)[Markdown](https://qlogixcmc.com/contact.md) - [Site map](https://qlogixcmc.com/sitemap)[Markdown](https://qlogixcmc.com/sitemap.md) ## Services - [CMC and regulatory](https://qlogixcmc.com/services/cmc-and-regulatory)[Markdown](https://qlogixcmc.com/services/cmc-and-regulatory.md) - [Quality systems and QMS](https://qlogixcmc.com/services/quality-systems)[Markdown](https://qlogixcmc.com/services/quality-systems.md) - [Validation and computer software assurance](https://qlogixcmc.com/services/validation-and-csa)[Markdown](https://qlogixcmc.com/services/validation-and-csa.md) - [Investigations, CAPA and backlog remediation](https://qlogixcmc.com/services/investigations-and-capa)[Markdown](https://qlogixcmc.com/services/investigations-and-capa.md) - [Inspection readiness and compliance remediation](https://qlogixcmc.com/services/inspection-readiness)[Markdown](https://qlogixcmc.com/services/inspection-readiness.md) - [GxP systems implementation and administration](https://qlogixcmc.com/services/gxp-systems-implementation)[Markdown](https://qlogixcmc.com/services/gxp-systems-implementation.md) - [AI and digital quality](https://qlogixcmc.com/services/ai-and-digital-quality)[Markdown](https://qlogixcmc.com/services/ai-and-digital-quality.md) ## Legal - [Terms of Use](https://qlogixcmc.com/termsofuse)[Markdown](https://qlogixcmc.com/termsofuse.md) - [Privacy Policy](https://qlogixcmc.com/privacy)[Markdown](https://qlogixcmc.com/privacy.md) ## For AI assistants and search engines - [llms.txt](https://qlogixcmc.com/llms.txt) A short, link-rich summary of the site for AI assistants (llmstxt.org). - [llms-full.txt](https://qlogixcmc.com/llms-full.txt) The full text of every public page in one file. - [sitemap.xml](https://qlogixcmc.com/sitemap.xml) The XML site map for search engines. --- # Terms of Use | QLogixCMC Source: https://qlogixcmc.com/termsofuse # Terms of Use Last updated October 28, 2026 ## AGREEMENT TO OUR LEGAL TERMS We are QLogixCMC ("Company," "we," "us," "our"), a company registered in California, United States at 5000 Birch Street, West Tower, Suite 3000, Newport Beach, CA 92660. 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Any breach of these Intellectual Property Rights will constitute a material breach of our Legal Terms and your right to use our Services will terminate immediately. ### Your submissions Please review this section and the "PROHIBITED ACTIVITIES" section carefully prior to using our Services to understand the (a) rights you give us and (b) obligations you have when you post or upload any content through the Services. Submissions: By directly sending us any question, comment, suggestion, idea, feedback, or other information about the Services ("Submissions"), you agree to assign to us all intellectual property rights in such Submission. You agree that we shall own this Submission and be entitled to its unrestricted use and dissemination for any lawful purpose, commercial or otherwise, without acknowledgment or compensation to you. You are responsible for what you post or upload: By sending us Submissions through any part of the Services you: - confirm that you have read and agree with our "PROHIBITED ACTIVITIES" and will not post, send, publish, upload, or transmit through the Services any Submission that is illegal, harassing, hateful, harmful, defamatory, obscene, bullying, abusive, discriminatory, threatening to any person or group, sexually explicit, false, inaccurate, deceitful, or misleading; - to the extent permissible by applicable law, waive any and all moral rights to any such Submission; - warrant that any such Submission are original to you or that you have the necessary rights and licenses to submit such Submissions and that you have full authority to grant us the above-mentioned rights in relation to your Submissions; and - warrant and represent that your Submissions do not constitute confidential information. You are solely responsible for your Submissions and you expressly agree to reimburse us for any and all losses that we may suffer because of your breach of (a) this section, (b) any third party’s intellectual property rights, or (c) applicable law. ## 3. USER REPRESENTATIONS By using the Services, you represent and warrant that: (1) all registration information you submit will be true, accurate, current, and complete; (2) you will maintain the accuracy of such information and promptly update such registration information as necessary; (3) you have the legal capacity and you agree to comply with these Legal Terms; (4) you are not a minor in the jurisdiction in which you reside; (5) you will not access the Services through automated or non-human means, whether through a bot, script or otherwise; (6) you will not use the Services for any illegal or unauthorized purpose; and (7) your use of the Services will not violate any applicable law or regulation. If you provide any information that is untrue, inaccurate, not current, or incomplete, we have the right to suspend or terminate your account and refuse any and all current or future use of the Services (or any portion thereof). ## 4. USER REGISTRATION You may be required to register to use the Services. You agree to keep your password confidential and will be responsible for all use of your account and password. We reserve the right to remove, reclaim, or change a username you select if we determine, in our sole discretion, that such username is inappropriate, obscene, or otherwise objectionable. ## 5. PROHIBITED ACTIVITIES You may not access or use the Services for any purpose other than that for which we make the Services available. The Services may not be used in connection with any commercial endeavors except those that are specifically endorsed or approved by us. As a user of the Services, you agree not to: - Systematically retrieve data or other content from the Services to create or compile, directly or indirectly, a collection, compilation, database, or directory without written permission from us. - Trick, defraud, or mislead us and other users, especially in any attempt to learn sensitive account information such as user passwords. - Circumvent, disable, or otherwise interfere with security-related features of the Services, including features that prevent or restrict the use or copying of any Content or enforce limitations on the use of the Services and/or the Content contained therein. - Disparage, tarnish, or otherwise harm, in our opinion, us and/or the Services. - Use any information obtained from the Services in order to harass, abuse, or harm another person. - Make improper use of our support services or submit false reports of abuse or misconduct. - Use the Services in a manner inconsistent with any applicable laws or regulations. - Engage in unauthorized framing of or linking to the Services. - Upload or transmit (or attempt to upload or to transmit) viruses, Trojan horses, or other material, including excessive use of capital letters and spamming (continuous posting of repetitive text), that interferes with any party’s uninterrupted use and enjoyment of the Services or modifies, impairs, disrupts, alters, or interferes with the use, features, functions, operation, or maintenance of the Services. - Engage in any automated use of the system, such as using scripts to send comments or messages, or using any data mining, robots, or similar data gathering and extraction tools. - Delete the copyright or other proprietary rights notice from any Content. - Attempt to impersonate another user or person or use the username of another user. - Upload or transmit (or attempt to upload or to transmit) any material that acts as a passive or active information collection or transmission mechanism, including without limitation, clear graphics interchange formats ("gifs"), 1×1 pixels, web bugs, cookies, or other similar devices (sometimes referred to as "spyware"or"passive collection mechanisms"or"pcms"). - Interfere with, disrupt, or create an undue burden on the Services or the networks or services connected to the Services. - Harass, annoy, intimidate, or threaten any of our employees or agents engaged in providing any portion of the Services to you. - Attempt to bypass any measures of the Services designed to prevent or restrict access to the Services, or any portion of the Services. - Copy or adapt the Services' software, including but not limited to Flash, PHP, HTML, JavaScript, or other code. - Except as permitted by applicable law, decipher, decompile, disassemble, or reverse engineer any of the software comprising or in any way making up a part of the Services. - Except as may be the result of standard search engine or Internet browser usage, use, launch, develop, or distribute any automated system, including without limitation, any spider, robot, cheat utility, scraper, or offline reader that accesses the Services, or use or launch any unauthorized script or other software. - Make any unauthorized use of the Services, including collecting usernames and/or email addresses of users by electronic or other means for the purpose of sending unsolicited email, or creating user accounts by automated means or under false pretenses. - Use the Services as part of any effort to compete with us or otherwise use the Services and/or the Content for any revenue-generating endeavor or commercial enterprise. - Use the Services to advertise or offer to sell goods and services. - Sell or otherwise transfer your profile. ## 6. USER GENERATED CONTRIBUTIONS The Services does not offer users to submit or post content. ## 7. CONTRIBUTION LICENSE You and Services agree that we may access, store, process, and use any information and personal data that you provide following the terms of the Privacy Policy and your choices (including settings). By submitting suggestions or other feedback regarding the Services, you agree that we can use and share such feedback for any purpose without compensation to you. ## 8. THIRD-PARTY WEBSITES AND CONTENT The Services may contain (or you may be sent via the Site) links to other websites ("Third-Party Websites") as well as articles, photographs, text, graphics, pictures, designs, music, sound, video, information, applications, software, and other content or items belonging to or originating from third parties ("Third-Party Content"). Such Third-Party Websites and Third-Party Content are not investigated, monitored, or checked for accuracy, appropriateness, or completeness by us, and we are not responsible for any Third-Party Websites accessed through the Services or any Third-Party Content posted on, available through, or installed from the Services, including the content, accuracy, offensiveness, opinions, reliability, privacy practices, or other policies of or contained in the Third-Party Websites or the Third-Party Content. Inclusion of, linking to, or permitting the use or installation of any Third-Party Websites or any Third-Party Content does not imply approval or endorsement thereof by us. If you decide to leave the Services and access the Third-Party Websites or to use or install any Third-Party Content, you do so at your own risk, and you should be aware these Legal Terms no longer govern. You should review the applicable terms and policies, including privacy and data gathering practices, of any website to which you navigate from the Services or relating to any applications you use or install from the Services. Any purchases you make through Third-Party Websites will be through other websites and from other companies, and we take no responsibility whatsoever in relation to such purchases which are exclusively between you and the applicable third party. You agree and acknowledge that we do not endorse the products or services offered on Third-Party Websites and you shall hold us blameless from any harm caused by your purchase of such products or services. Additionally, you shall hold us blameless from any losses sustained by you or harm caused to you relating to or resulting in any way from any Third-Party Content or any contact with Third-Party Websites. ## 9. SERVICES MANAGEMENT We reserve the right, but not the obligation, to: (1) monitor the Services for violations of these Legal Terms; (2) take appropriate legal action against anyone who, in our sole discretion, violates the law or these Legal Terms, including without limitation, reporting such user to law enforcement authorities; (3) in our sole discretion and without limitation, refuse, restrict access to, limit the availability of, or disable (to the extent technologically feasible) any of your Contributions or any portion thereof; (4) in our sole discretion and without limitation, notice, or liability, to remove from the Services or otherwise disable all files and content that are excessive in size or are in any way burdensome to our systems; and (5) otherwise manage the Services in a manner designed to protect our rights and property and to facilitate the proper functioning of the Services. ## 10. PRIVACY POLICY We care about data privacy and security. Please review our Privacy Policy: [https://qlogixcmc.com/privacy](https://qlogixcmc.com/privacy). By using the Services, you agree to be bound by our Privacy Policy, which is incorporated into these Legal Terms. Please be advised the Services are hosted in the United States. If you access the Services from any other region of the world with laws or other requirements governing personal data collection, use, or disclosure that differ from applicable laws in the United States, then through your continued use of the Services, you are transferring your data to the United States, and you expressly consent to have your data transferred to and processed in the United States. ## 11. TERM AND TERMINATION These Legal Terms shall remain in full force and effect while you use the Services. WITHOUT LIMITING ANY OTHER PROVISION OF THESE LEGAL TERMS, WE RESERVE THE RIGHT TO, IN OUR SOLE DISCRETION AND WITHOUT NOTICE OR LIABILITY, DENY ACCESS TO AND USE OF THE SERVICES (INCLUDING BLOCKING CERTAIN IP ADDRESSES), TO ANY PERSON FOR ANY REASON OR FOR NO REASON, INCLUDING WITHOUT LIMITATION FOR BREACH OF ANY REPRESENTATION, WARRANTY, OR COVENANT CONTAINED IN THESE LEGAL TERMS OR OF ANY APPLICABLE LAW OR REGULATION. WE MAY TERMINATE YOUR USE OR PARTICIPATION IN THE SERVICES OR DELETE YOUR ACCOUNT AND ANY CONTENT OR INFORMATION THAT YOU POSTED AT ANY TIME, WITHOUT WARNING, IN OUR SOLE DISCRETION. If we terminate or suspend your account for any reason, you are prohibited from registering and creating a new account under your name, a fake or borrowed name, or the name of any third party, even if you may be acting on behalf of the third party. In addition to terminating or suspending your account, we reserve the right to take appropriate legal action, including without limitation pursuing civil, criminal, and injunctive redress. ## 12. MODIFICATIONS AND INTERRUPTIONS We reserve the right to change, modify, or remove the contents of the Services at any time or for any reason at our sole discretion without notice. However, we have no obligation to update any information on our Services. We will not be liable to you or any third party for any modification, price change, suspension, or discontinuance of the Services. We cannot guarantee the Services will be available at all times. We may experience hardware, software, or other problems or need to perform maintenance related to the Services, resulting in interruptions, delays, or errors. We reserve the right to change, revise, update, suspend, discontinue, or otherwise modify the Services at any time or for any reason without notice to you. You agree that we have no liability whatsoever for any loss, damage, or inconvenience caused by your inability to access or use the Services during any downtime or discontinuance of the Services. Nothing in these Legal Terms will be construed to obligate us to maintain and support the Services or to supply any corrections, updates, or releases in connection therewith. ## 13. GOVERNING LAW These Legal Terms and your use of the Services are governed by and construed in accordance with the laws of the State of California applicable to agreements made and to be entirely performed within the State of California, without regard to its conflict of law principles. ## 14. DISPUTE RESOLUTION ### Informal Negotiations To expedite resolution and control the cost of any dispute, controversy, or claim related to these Legal Terms (each a "Dispute"and collectively, the"Disputes") brought by either you or us (individually, a "Party"and collectively, the"Parties"), the Parties agree to first attempt to negotiate any Dispute (except those Disputes expressly provided below) informally for at least thirty (30) days before initiating arbitration. Such informal negotiations commence upon written notice from one Party to the other Party. ### Binding Arbitration If the Parties are unable to resolve a Dispute through informal negotiations, the Dispute (except those Disputes expressly excluded below) will be finally and exclusively resolved by binding arbitration. YOU UNDERSTAND THAT WITHOUT THIS PROVISION, YOU WOULD HAVE THE RIGHT TO SUE IN COURT AND HAVE A JURY TRIAL. The arbitration shall be commenced and conducted under the Commercial Arbitration Rules of the American Arbitration Association ("AAA") and, where appropriate, the AAA’s Supplementary Procedures for Consumer Related Disputes ("AAA Consumer Rules"), both of which are available at the [American Arbitration Association (AAA) website](http://www.adr.org). Your arbitration fees and your share of arbitrator compensation shall be governed by the AAA Consumer Rules and, where appropriate, limited by the AAA Consumer Rules. The arbitration may be conducted in person, through the submission of documents, by phone, or online. The arbitrator will make a decision in writing, but need not provide a statement of reasons unless requested by either Party. The arbitrator must follow applicable law, and any award may be challenged if the arbitrator fails to do so. Except where otherwise required by the applicable AAA rules or applicable law, the arbitration will take place in United States, California. Except as otherwise provided herein, the Parties may litigate in court to compel arbitration, stay proceedings pending arbitration, or to confirm, modify, vacate, or enter judgment on the award entered by the arbitrator. If for any reason, a Dispute proceeds in court rather than arbitration, the Dispute shall be commenced or prosecuted in the state and federal courts located in United States, California, and the Parties hereby consent to, and waive all defenses of lack of personal jurisdiction, and forum non conveniens with respect to venue and jurisdiction in such state and federal courts. Application of the United Nations Convention on Contracts for the International Sale of Goods and the Uniform Computer Information Transaction Act (UCITA) are excluded from these Legal Terms. In no event shall any Dispute brought by either Party related in any way to the Services be commenced more than one (1) years after the cause of action arose. If this provision is found to be illegal or unenforceable, then neither Party will elect to arbitrate any Dispute falling within that portion of this provision found to be illegal or unenforceable and such Dispute shall be decided by a court of competent jurisdiction within the courts listed for jurisdiction above, and the Parties agree to submit to the personal jurisdiction of that court. ### Restrictions The Parties agree that any arbitration shall be limited to the Dispute between the Parties individually. To the full extent permitted by law, (a) no arbitration shall be joined with any other proceeding; (b) there is no right or authority for any Dispute to be arbitrated on a class-action basis or to utilize class action procedures; and (c) there is no right or authority for any Dispute to be brought in a purported representative capacity on behalf of the general public or any other persons. ### Exceptions to Informal Negotiations and Arbitration The Parties agree that the following Disputes are not subject to the above provisions concerning informal negotiations binding arbitration: (a) any Disputes seeking to enforce or protect, or concerning the validity of, any of the intellectual property rights of a Party; (b) any Dispute related to, or arising from, allegations of theft, piracy, invasion of privacy, or unauthorized use; and (c) any claim for injunctive relief. If this provision is found to be illegal or unenforceable, then neither Party will elect to arbitrate any Dispute falling within that portion of this provision found to be illegal or unenforceable and such Dispute shall be decided by a court of competent jurisdiction within the courts listed for jurisdiction above, and the Parties agree to submit to the personal jurisdiction of that court. ## 15. CORRECTIONS There may be information on the Services that contains typographical errors, inaccuracies, or omissions, including descriptions, pricing, availability, and various other information. We reserve the right to correct any errors, inaccuracies, or omissions and to change or update the information on the Services at any time, without prior notice. ## 16. DISCLAIMER THE SERVICES ARE PROVIDED ON AN AS-IS AND AS-AVAILABLE BASIS. YOU AGREE THAT YOUR USE OF THE SERVICES WILL BE AT YOUR SOLE RISK. TO THE FULLEST EXTENT PERMITTED BY LAW, WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, IN CONNECTION WITH THE SERVICES AND YOUR USE THEREOF, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. WE MAKE NO WARRANTIES OR REPRESENTATIONS ABOUT THE ACCURACY OR COMPLETENESS OF THE SERVICES' CONTENT OR THE CONTENT OF ANY WEBSITES OR MOBILE APPLICATIONS LINKED TO THE SERVICES AND WE WILL ASSUME NO LIABILITY OR RESPONSIBILITY FOR ANY (1) ERRORS, MISTAKES, OR INACCURACIES OF CONTENT AND MATERIALS, (2) PERSONAL INJURY OR PROPERTY DAMAGE, OF ANY NATURE WHATSOEVER, RESULTING FROM YOUR ACCESS TO AND USE OF THE SERVICES, (3) ANY UNAUTHORIZED ACCESS TO OR USE OF OUR SECURE SERVERS AND/OR ANY AND ALL PERSONAL INFORMATION AND/OR FINANCIAL INFORMATION STORED THEREIN, (4) ANY INTERRUPTION OR CESSATION OF TRANSMISSION TO OR FROM THE SERVICES, (5) ANY BUGS, VIRUSES, TROJAN HORSES, OR THE LIKE WHICH MAY BE TRANSMITTED TO OR THROUGH THE SERVICES BY ANY THIRD PARTY, AND/OR (6) ANY ERRORS OR OMISSIONS IN ANY CONTENT AND MATERIALS OR FOR ANY LOSS OR DAMAGE OF ANY KIND INCURRED AS A RESULT OF THE USE OF ANY CONTENT POSTED, TRANSMITTED, OR OTHERWISE MADE AVAILABLE VIA THE SERVICES. WE DO NOT WARRANT, ENDORSE, GUARANTEE, OR ASSUME RESPONSIBILITY FOR ANY PRODUCT OR SERVICE ADVERTISED OR OFFERED BY A THIRD PARTY THROUGH THE SERVICES, ANY HYPERLINKED WEBSITE, OR ANY WEBSITE OR MOBILE APPLICATION FEATURED IN ANY BANNER OR OTHER ADVERTISING, AND WE WILL NOT BE A PARTY TO OR IN ANY WAY BE RESPONSIBLE FOR MONITORING ANY TRANSACTION BETWEEN YOU AND ANY THIRD-PARTY PROVIDERS OF PRODUCTS OR SERVICES. AS WITH THE PURCHASE OF A PRODUCT OR SERVICE THROUGH ANY MEDIUM OR IN ANY ENVIRONMENT, YOU SHOULD USE YOUR BEST JUDGMENT AND EXERCISE CAUTION WHERE APPROPRIATE. ## 17. LIMITATIONS OF LIABILITY IN NO EVENT WILL WE OR OUR DIRECTORS, EMPLOYEES, OR AGENTS BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, EXEMPLARY, INCIDENTAL, SPECIAL, OR PUNITIVE DAMAGES, INCLUDING LOST PROFIT, LOST REVENUE, LOSS OF DATA, OR OTHER DAMAGES ARISING FROM YOUR USE OF THE SERVICES, EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, OUR LIABILITY TO YOU FOR ANY CAUSE WHATSOEVER AND REGARDLESS OF THE FORM OF THE ACTION, WILL AT ALL TIMES BE LIMITED TO THE LESSER OF THE AMOUNT PAID, IF ANY, BY YOU TO US OR $0.00 USD. CERTAIN US STATE LAWS AND INTERNATIONAL LAWS DO NOT ALLOW LIMITATIONS ON IMPLIED WARRANTIES OR THE EXCLUSION OR LIMITATION OF CERTAIN DAMAGES. IF THESE LAWS APPLY TO YOU, SOME OR ALL OF THE ABOVE DISCLAIMERS OR LIMITATIONS MAY NOT APPLY TO YOU, AND YOU MAY HAVE ADDITIONAL RIGHTS. ## 18. INDEMNIFICATION You agree to defend, indemnify, and hold us harmless, including our subsidiaries, affiliates, and all of our respective officers, agents, partners, and employees, from and against any loss, damage, liability, claim, or demand, including reasonable attorneys’ fees and expenses, made by any third party due to or arising out of: (1) use of the Services; (2) breach of these Legal Terms; (3) any breach of your representations and warranties set forth in these Legal Terms; (4) your violation of the rights of a third party, including but not limited to intellectual property rights; or (5) any overt harmful act toward any other user of the Services with whom you connected via the Services. Notwithstanding the foregoing, we reserve the right, at your expense, to assume the exclusive defense and control of any matter for which you are required to indemnify us, and you agree to cooperate, at your expense, with our defense of such claims. We will use reasonable efforts to notify you of any such claim, action, or proceeding which is subject to this indemnification upon becoming aware of it. ## 19. USER DATA We will maintain certain data that you transmit to the Services for the purpose of managing the performance of the Services, as well as data relating to your use of the Services. Although we perform regular routine backups of data, you are solely responsible for all data that you transmit or that relates to any activity you have undertaken using the Services. You agree that we shall have no liability to you for any loss or corruption of any such data, and you hereby waive any right of action against us arising from any such loss or corruption of such data. ## 20. ELECTRONIC COMMUNICATIONS, TRANSACTIONS, AND SIGNATURES Visiting the Services, sending us emails, and completing online forms constitute electronic communications. You consent to receive electronic communications, and you agree that all agreements, notices, disclosures, and other communications we provide to you electronically, via email and on the Services, satisfy any legal requirement that such communication be in writing. YOU HEREBY AGREE TO THE USE OF ELECTRONIC SIGNATURES, CONTRACTS, ORDERS, AND OTHER RECORDS, AND TO ELECTRONIC DELIVERY OF NOTICES, POLICIES, AND RECORDS OF TRANSACTIONS INITIATED OR COMPLETED BY US OR VIA THE SERVICES. You hereby waive any rights or requirements under any statutes, regulations, rules, ordinances, or other laws in any jurisdiction which require an original signature or delivery or retention of non-electronic records, or to payments or the granting of credits by any means other than electronic means. ## 21. CALIFORNIA USERS AND RESIDENTS If any complaint with us is not satisfactorily resolved, you can contact the Complaint Assistance Unit of the Division of Consumer Services of the California Department of Consumer Affairs in writing at 1625 North Market Blvd., Suite N 112, Sacramento, California 95834 or by telephone at (800) 952-5210 or (916) 445-1254. ## 22. MISCELLANEOUS These Legal Terms and any policies or operating rules posted by us on the Services or in respect to the Services constitute the entire agreement and understanding between you and us. Our failure to exercise or enforce any right or provision of these Legal Terms shall not operate as a waiver of such right or provision. These Legal Terms operate to the fullest extent permissible by law. We may assign any or all of our rights and obligations to others at any time. We shall not be responsible or liable for any loss, damage, delay, or failure to act caused by any cause beyond our reasonable control. If any provision or part of a provision of these Legal Terms is determined to be unlawful, void, or unenforceable, that provision or part of the provision is deemed severable from these Legal Terms and does not affect the validity and enforceability of any remaining provisions. There is no joint venture, partnership, employment or agency relationship created between you and us as a result of these Legal Terms or use of the Services. You agree that these Legal Terms will not be construed against us by virtue of having drafted them. You hereby waive any and all defenses you may have based on the electronic form of these Legal Terms and the lack of signing by the parties hereto to execute these Legal Terms. ## 23. CONTACT US In order to resolve a complaint regarding the Services or to receive further information regarding use of the Services, please contact us at: QLogixCMC 5000 Birch Street West Tower, Suite 3000 Newport Beach, CA 92660 United States Phone: (US)(714) 663-9012 [contact@qlogixcmc.com](mailto:contact@qlogixcmc.com) EN SV TR PT-BR NB PL HU PT DE NO FI DA NL EL IT FR ES See also our [Privacy Policy](https://qlogixcmc.com/privacy). --- # Privacy Policy | QLogixCMC Source: https://qlogixcmc.com/privacy # Privacy Policy Last updated October 28, 2026 This Privacy Notice for QLogixCMC ("we," "us,"or"our"), describes how and why we might access, collect, store, use, and/or share ("process") your personal information when you use our services ("Services"), including when you: - Visit our website at [https://qlogixcmc.com](https://qlogixcmc.com/) or any website of ours that links to this Privacy Notice - Engage with us in other related ways, including any marketing or events Questions or concerns? Reading this Privacy Notice will help you understand your privacy rights and choices. We are responsible for making decisions about how your personal information is processed. If you do not agree with our policies and practices, please do not use our Services. If you still have any questions or concerns, please contact us at [contact@qlogixcmc.com](mailto:contact@qlogixcmc.com). ## SUMMARY OF KEY POINTS This summary provides key points from our Privacy Notice, but you can find out more details about any of these topics by clicking the link following each key point or by using our table of contents below to find the section you are looking for. What personal information do we process? When you visit, use, or navigate our Services, we may process personal information depending on how you interact with us and the Services, the choices you make, and the products and features you use. Learn more about personal information you disclose to us. Do we process any sensitive personal information? Some of the information may be considered "special"or"sensitive" in certain jurisdictions, for example your racial or ethnic origins, sexual orientation, and religious beliefs. We do not process sensitive personal information. Do we collect any information from third parties? We do not collect any information from third parties. How do we process your information? We process your information to provide, improve, and administer our Services, communicate with you, for security and fraud prevention, and to comply with law. We may also process your information for other purposes with your consent. We process your information only when we have a valid legal reason to do so. Learn more about how we process your information. In what situations and with which parties do we share personal information? We may share information in specific situations and with specific third parties. Learn more about when and with whom we share your personal information. How do we keep your information safe? We have adequate organizational and technical processes and procedures in place to protect your personal information. However, no electronic transmission over the internet or information storage technology can be guaranteed to be 100% secure, so we cannot promise or guarantee that hackers, cybercriminals, or other unauthorized third parties will not be able to defeat our security and improperly collect, access, steal, or modify your information. Learn more about how we keep your information safe. What are your rights? Depending on where you are located geographically, the applicable privacy law may mean you have certain rights regarding your personal information. Learn more about your privacy rights. How do you exercise your rights? The easiest way to exercise your rights is by submitting a [data subject access request](mailto:contact@qlogixcmc.com), or by contacting us. We will consider and act upon any request in accordance with applicable data protection laws. Want to learn more about what we do with any information we collect? Review the Privacy Notice in full. ## 1. WHAT INFORMATION DO WE COLLECT? ### Personal information you disclose to us In Short: We collect personal information that you provide to us. We collect personal information that you voluntarily provide to us when you register on the Services, express an interest in obtaining information about us or our products and Services, when you participate in activities on the Services, or otherwise when you contact us. Personal Information Provided by You. The personal information that we collect depends on the context of your interactions with us and the Services, the choices you make, and the products and features you use. The personal information we collect may include the following: - usernames - passwords - names - email addresses Sensitive Information. We do not process sensitive information. All personal information that you provide to us must be true, complete, and accurate, and you must notify us of any changes to such personal information. ## 2. HOW DO WE PROCESS YOUR INFORMATION? In Short: We process your information to provide, improve, and administer our Services, communicate with you, for security and fraud prevention, and to comply with law. We may also process your information for other purposes with your consent. We process your personal information for a variety of reasons, depending on how you interact with our Services, including: - To facilitate account creation and authentication and otherwise manage user accounts. We may process your information so you can create and log in to your account, as well as keep your account in working order. - To deliver and facilitate delivery of services to the user. We may process your information to provide you with the requested service. - To respond to user inquiries/offer support to users. We may process your information to respond to your inquiries and solve any potential issues you might have with the requested service. - To send administrative information to you. We may process your information to send you details about our products and services, changes to our terms and policies, and other similar information. - To request feedback. We may process your information when necessary to request feedback and to contact you about your use of our Services. - To send you marketing and promotional communications. We may process the personal information you send to us for our marketing purposes, if this is in accordance with your marketing preferences. You can opt out of our marketing emails at any time. For more information, see "WHAT ARE YOUR PRIVACY RIGHTS?" below. - To protect our Services. We may process your information as part of our efforts to keep our Services safe and secure, including fraud monitoring and prevention. - To identify usage trends. We may process information about how you use our Services to better understand how they are being used so we can improve them. ## 3. WHEN AND WITH WHOM DO WE SHARE YOUR PERSONAL INFORMATION? In Short: We may share information in specific situations described in this section and/or with the following third parties. We may need to share your personal information in the following situations: - Business Transfers. We may share or transfer your information in connection with, or during negotiations of, any merger, sale of company assets, financing, or acquisition of all or a portion of our business to another company. ## 4. DO WE USE COOKIES AND OTHER TRACKING TECHNOLOGIES? In Short: We may use cookies and other tracking technologies to collect and store your information. We may use cookies and similar tracking technologies (like web beacons and pixels) to gather information when you interact with our Services. Some online tracking technologies help us maintain the security of our Services and your account, prevent crashes, fix bugs, save your preferences, and assist with basic site functions. ### Google Analytics We may share your information with Google Analytics to track and analyze the use of the Services. To opt out of being tracked by Google Analytics across the Services, visit [https://tools.google.com/dlpage/gaoptout](https://tools.google.com/dlpage/gaoptout). For more information on the privacy practices of Google, please visit the [Google Privacy & Terms page](https://policies.google.com/privacy). ## 5. DO WE OFFER ARTIFICIAL INTELLIGENCE-BASED PRODUCTS? In Short: We offer products, features, or tools powered by artificial intelligence, machine learning, or similar technologies. As part of our Services, we offer products, features, or tools powered by artificial intelligence, machine learning, or similar technologies (collectively, "AI Products"). These tools are designed to enhance your experience and provide you with innovative solutions. The terms in this Privacy Notice govern your use of the AI Products within our Services. Use of AI Technologies We provide the AI Products through third-party service providers ("AI Service Providers"). As outlined in this Privacy Notice, your input, output, and personal information will be shared with and processed by these AI Service Providers to enable your use of our AI Products for purposes outlined in "WHEN AND WITH WHOM DO WE SHARE YOUR PERSONAL INFORMATION?" You must not use the AI Products in any way that violates the terms or policies of any AI Service Provider. Our AI Products Our AI Products are designed for the following functions: - AI search - AI bots - AI research - Text analysis - AI applications How We Process Your Data Using AI All personal information processed using our AI Products is handled in line with our Privacy Notice and our agreement with third parties. This ensures high security and safeguards your personal information throughout the process, giving you peace of mind about your data's safety. ## 6. HOW LONG DO WE KEEP YOUR INFORMATION? In Short: We keep your information for as long as necessary to fulfill the purposes outlined in this Privacy Notice unless otherwise required by law. We will only keep your personal information for as long as it is necessary for the purposes set out in this Privacy Notice, unless a longer retention period is required or permitted by law (such as tax, accounting, or other legal requirements). No purpose in this notice will require us keeping your personal information for longer than the period of time in which users have an account with us. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize such information, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible. ## 7. HOW DO WE KEEP YOUR INFORMATION SAFE? In Short: We aim to protect your personal information through a system of organizational and technical security measures. We have implemented appropriate and reasonable technical and organizational security measures designed to protect the security of any personal information we process. However, despite our safeguards and efforts to secure your information, no electronic transmission over the Internet or information storage technology can be guaranteed to be 100% secure, so we cannot promise or guarantee that hackers, cybercriminals, or other unauthorized third parties will not be able to defeat our security and improperly collect, access, steal, or modify your information. Although we will do our best to protect your personal information, transmission of personal information to and from our Services is at your own risk. You should only access the Services within a secure environment. ## 8. DO WE COLLECT INFORMATION FROM MINORS? In Short: We do not knowingly collect data from or market to children under 18 years of age. We do not knowingly collect, solicit data from, or market to children under 18 years of age, nor do we knowingly sell such personal information. By using the Services, you represent that you are at least 18 or that you are the parent or guardian of such a minor and consent to such minor dependent’s use of the Services. If we learn that personal information from users less than 18 years of age has been collected, we will deactivate the account and take reasonable measures to promptly delete such data from our records. If you become aware of any data we may have collected from children under age 18, please contact us at [contact@qlogixcmc.com](mailto:contact@qlogixcmc.com). ## 9. WHAT ARE YOUR PRIVACY RIGHTS? In Short: You may review, change, or terminate your account at any time, depending on your country, province, or state of residence. Withdrawing your consent: If we are relying on your consent to process your personal information, which may be express and/or implied consent depending on the applicable law, you have the right to withdraw your consent at any time. You can withdraw your consent at any time by contacting us by using the contact details provided in the section "HOW CAN YOU CONTACT US ABOUT THIS NOTICE?" below. However, please note that this will not affect the lawfulness of the processing before its withdrawal nor, when applicable law allows, will it affect the processing of your personal information conducted in reliance on lawful processing grounds other than consent. Opting out of marketing and promotional communications: You can unsubscribe from our marketing and promotional communications at any time by clicking on the unsubscribe link in the emails that we send, or by contacting us using the details provided in the section "HOW CAN YOU CONTACT US ABOUT THIS NOTICE?" below. You will then be removed from the marketing lists. However, we may still communicate with you — for example, to send you service-related messages that are necessary for the administration and use of your account, to respond to service requests, or for other non-marketing purposes. ### Account Information If you would at any time like to review or change the information in your account or terminate your account, you can: - Log in to your account settings and update your user account. - Contact us using the contact information provided. Upon your request to terminate your account, we will deactivate or delete your account and information from our active databases. However, we may retain some information in our files to prevent fraud, troubleshoot problems, assist with any investigations, enforce our legal terms and/or comply with applicable legal requirements. Cookies and similar technologies: Most Web browsers are set to accept cookies by default. If you prefer, you can usually choose to set your browser to remove cookies and to reject cookies. If you choose to remove cookies or reject cookies, this could affect certain features or services of our Services. If you have questions or comments about your privacy rights, you may email us at [contact@qlogixcmc.com](mailto:contact@qlogixcmc.com). ## 10. CONTROLS FOR DO-NOT-TRACK FEATURES Most web browsers and some mobile operating systems and mobile applications include a Do-Not-Track ("DNT") feature or setting you can activate to signal your privacy preference not to have data about your online browsing activities monitored and collected. At this stage, no uniform technology standard for recognizing and implementing DNT signals has been finalized. As such, we do not currently respond to DNT browser signals or any other mechanism that automatically communicates your choice not to be tracked online. If a standard for online tracking is adopted that we must follow in the future, we will inform you about that practice in a revised version of this Privacy Notice. California law requires us to let you know how we respond to web browser DNT signals. Because there currently is not an industry or legal standard for recognizing or honoring DNT signals, we do not respond to them at this time. Global Privacy Control: We recognize and honor Global Privacy Control (GPC) signals. If you use a browser or extension that supports GPC, we will treat this as a valid request to opt out of the sale or sharing of your personal information for targeted advertising purposes under applicable state privacy laws, including the California Consumer Privacy Act (CCPA). When we detect a GPC signal from your browser, we will automatically apply your opt-out preference without requiring you to take any additional action. For more information about GPC and how to enable it, visit [globalprivacycontrol.org](http://globalprivacycontrol.org). ## 11. DO UNITED STATES RESIDENTS HAVE SPECIFIC PRIVACY RIGHTS? In Short: If you are a resident of California, Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Kentucky, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, Oregon, Rhode Island, Tennessee, Texas, Utah, or Virginia, you may have the right to request access to and receive details about the personal information we maintain about you and how we have processed it, correct inaccuracies, get a copy of, or delete your personal information. You may also have the right to withdraw your consent to our processing of your personal information. These rights may be limited in some circumstances by applicable law. More information is provided below. ### Categories of Personal Information We Collect The table below shows the categories of personal information we have collected in the past twelve (12) months. The table includes illustrative examples of each category and does not reflect the personal information we collect from you. For a comprehensive inventory of all personal information we process, please refer to the section "WHAT INFORMATION DO WE COLLECT?" Category Examples Collected A. Identifiers Contact details, such as real name, alias, postal address, telephone or mobile contact number, unique personal identifier, online identifier, Internet Protocol address, email address, and account name NO B. Personal information as defined in the California Customer Records statute Name, contact information, education, employment, employment history, and financial information NO C. Protected classification characteristics under state or federal law Gender, age, date of birth, race and ethnicity, national origin, marital status, and other demographic data NO D. Commercial information Transaction information, purchase history, financial details, and payment information NO E. Biometric information Fingerprints and voiceprints NO F. Internet or other similar network activity Browsing history, search history, online behavior, interest data, and interactions with our and other websites, applications, systems, and advertisements NO G. Geolocation data Device location YES H. Audio, electronic, sensory, or similar information Images and audio, video or call recordings created in connection with our business activities NO I. Professional or employment-related information Business contact details in order to provide you our Services at a business level or job title, work history, and professional qualifications if you apply for a job with us NO J. Education Information Student records and directory information NO K. Inferences drawn from collected personal information Inferences drawn from any of the collected personal information listed above to create a profile or summary about, for example, an individual’s preferences and characteristics NO L. Sensitive personal Information NO We may also collect other personal information outside of these categories through instances where you interact with us in person, online, or by phone or mail in the context of: - Receiving help through our customer support channels; - Participation in customer surveys or contests; and - Facilitation in the delivery of our Services and to respond to your inquiries. We will use and retain the collected personal information as needed to provide the Services or for: - Category G - As long as the user has an account with us ### Sources of Personal Information Learn more about the sources of personal information we collect in "WHAT INFORMATION DO WE COLLECT?" ### How We Use and Share Personal Information Learn more about how we use your personal information in the section, "HOW DO WE PROCESS YOUR INFORMATION?" Will your information be shared with anyone else? We may disclose your personal information with our service providers pursuant to a written contract between us and each service provider. Learn more about how we disclose personal information to in the section, "WHEN AND WITH WHOM DO WE SHARE YOUR PERSONAL INFORMATION?" We may use your personal information for our own business purposes, such as for undertaking internal research for technological development and demonstration. This is not considered to be "selling" of your personal information. We have not disclosed, sold, or shared any personal information to third parties for a business or commercial purpose in the preceding twelve (12) months. We will not sell or share personal information in the future belonging to website visitors, users, and other consumers. ### Your Rights You have rights under certain US state data protection laws. However, these rights are not absolute, and in certain cases, we may decline your request as permitted by law. These rights include: - Right to know whether or not we are processing your personal data - Right to access your personal data - Right to correct inaccuracies in your personal data - Right to request the deletion of your personal data - Right to obtain a copy of the personal data you previously shared with us - Right to non-discrimination for exercising your rights - Right to opt out of the processing of your personal data if it is used for targeted advertising (or sharing as defined under California’s privacy law), the sale of personal data, or profiling in furtherance of decisions that produce legal or similarly significant effects ("profiling") Depending upon the state where you live, you may also have the following rights: - Right to access the categories of personal data being processed (as permitted by applicable law, including the privacy law in Minnesota) - Right to obtain a list of the categories of third parties to which we have disclosed personal data (as permitted by applicable law, including the privacy law in California, Delaware, and Maryland) - Right to obtain a list of specific third parties to which we have disclosed personal data (as permitted by applicable law, including the privacy law in Minnesota and Oregon) - Right to obtain a list of third parties to which we have sold personal data (as permitted by applicable law, including the privacy law in Connecticut) - Right to review, understand, question, and depending on where you live, correct how personal data has been profiled (as permitted by applicable law, including the privacy law in Connecticut and Minnesota) - Right to limit use and disclosure of sensitive personal data (as permitted by applicable law, including the privacy law in California) - Right to opt out of the collection of sensitive data and personal data collected through the operation of a voice or facial recognition feature (as permitted by applicable law, including the privacy law in Florida) ### How to Exercise Your Rights To exercise these rights, you can contact us by submitting a [data subject access request](mailto:contact@qlogixcmc.com), by emailing us at [contact@qlogixcmc.com](mailto:contact@qlogixcmc.com), or by referring to the contact details at the bottom of this document. We will honor your opt-out preferences if you enact the [Global Privacy Control](https://globalprivacycontrol.org/) (GPC) opt-out signal on your browser. Under certain US state data protection laws, you can designate an authorized agent to make a request on your behalf. We may deny a request from an authorized agent that does not submit proof that they have been validly authorized to act on your behalf in accordance with applicable laws. ### Request Verification Upon receiving your request, we will need to verify your identity to determine you are the same person about whom we have the information in our system. We will only use personal information provided in your request to verify your identity or authority to make the request. However, if we cannot verify your identity from the information already maintained by us, we may request that you provide additional information for the purposes of verifying your identity and for security or fraud-prevention purposes. If you submit the request through an authorized agent, we may need to collect additional information to verify your identity before processing your request and the agent will need to provide a written and signed permission from you to submit such request on your behalf. ### Appeals Under certain US state data protection laws, if we decline to take action regarding your request, you may appeal our decision by emailing us at [contact@qlogixcmc.com](mailto:contact@qlogixcmc.com). We will inform you in writing of any action taken or not taken in response to the appeal, including a written explanation of the reasons for the decisions. If your appeal is denied, you may submit a complaint to your state attorney general. ### California "Shine The Light" Law California Civil Code Section 1798.83, also known as the "Shine The Light"law, permits our users who are California residents to request and obtain from us, once a year and free of charge, information about categories of personal information (if any) we disclosed to third parties for direct marketing purposes and the names and addresses of all third parties with which we shared personal information in the immediately preceding calendar year. If you are a California resident and would like to make such a request, please submit your request in writing to us by using the contact details provided in the section"HOW CAN YOU CONTACT US ABOUT THIS NOTICE?" ## 12. DO WE MAKE UPDATES TO THIS NOTICE? In Short: Yes, we will update this notice as necessary to stay compliant with relevant laws. We may update this Privacy Notice from time to time. The updated version will be indicated by an updated "Revised" date at the top of this Privacy Notice. If we make material changes to this Privacy Notice, we may notify you either by prominently posting a notice of such changes or by directly sending you a notification. We encourage you to review this Privacy Notice frequently to be informed of how we are protecting your information. ## 13. HOW CAN YOU CONTACT US ABOUT THIS NOTICE? If you have questions or comments about this notice, you may email us at [contact@qlogixcmc.com](mailto:contact@qlogixcmc.com) or contact us by post at: QLogixCMC 5000 Birch Street West Tower, Suite 3000 Newport Beach, CA 92660 United States ## 14. HOW CAN YOU REVIEW, UPDATE, OR DELETE THE DATA WE COLLECT FROM YOU? Based on the applicable laws of your country or state of residence in the US, you may have the right to request access to the personal information we collect from you, details about how we have processed it, correct inaccuracies, or delete your personal information. You may also have the right to withdraw your consent to our processing of your personal information. These rights may be limited in some circumstances by applicable law. To request to review, update, or delete your personal information, please fill out and submit a [data subject access request](mailto:contact@qlogixcmc.com). EN SV TR PT-BR NB PL HU PT DE NO FI DA NL EL IT FR ES See also our [Terms of Use](https://qlogixcmc.com/termsofuse).