--- title: "AI governance and validation for GxP quality systems | QLogixCMC" description: "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." url: https://qlogixcmc.com/services/ai-and-digital-quality markdown: https://qlogixcmc.com/services/ai-and-digital-quality.md publisher: "QLogixCMC (QLogixCMC LLC)" language: en-US --- # 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 ## 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. - [Quality systems and QMS](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.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. - [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. 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