---
title: "Pharmaceutical quality system and QMS consulting | QLogixCMC"
description: "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."
url: https://qlogixcmc.com/services/quality-systems
markdown: https://qlogixcmc.com/services/quality-systems.md
publisher: "QLogixCMC (QLogixCMC LLC)"
language: en-US
---

# 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

## More from QLogixCMC

- [CMC and regulatory](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.
- [Validation and computer software assurance](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.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.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.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.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.
- [QLogixCMC home](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.md): QLogixCMC services, on site or remote: CMC and regulatory, quality systems, validation and CSA, investigations and CAPA, inspection readiness, GxP systems and AI.
- [Request a meeting](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.
- [llms.txt: a summary of the site for AI assistants](https://qlogixcmc.com/llms.txt)
- [Site map](https://qlogixcmc.com/sitemap.md)

---
Source: https://qlogixcmc.com/services/quality-systems
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