AI Compliance · 3 weeks

21 CFR Part 11 / EU Annex 11 — AI Systems Assessment

A focused compliance assessment for AI systems running inside your GxP-regulated environment. We map your AI deployment against 21 CFR Part 11, EU Annex 11, and the QGI decision-grade framework — then deliver a remediation plan that survives an FDA / EMA inspection.

Price

From $500

scoped per system complexity

SLA

3 weeks

end-to-end turnaround

For

Any GxP firm

deploying AI in QMS workflows

What We Assess

  • System Validation (CSV)

    IQ / OQ / PQ documentation, risk-based GAMP 5 categorization, and AI-specific validation considerations (model drift, retraining cycles, prompt-template change control).

  • Audit Trail Adequacy

    Tamper-evident logging of every AI input, every model version, every prompt, every output. Aligned with Part 11 §11.10(e).

  • Electronic Signature

    Where AI outputs require sign-off — who signs what, on which output, with what binding identity. Part 11 §11.50–11.300.

  • Data Integrity (ALCOA+)

    Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. AI-specific gaps flagged.

  • QGI Decision-Grade Mapping

    How your AI deployment scores on Replayable / Signable / Defensible — the QGI framework regulators are converging on.

  • Annex 11 Specifics

    For EU operations: §3 (Suppliers), §4 (Project Phase), §6 (Accuracy Checks), §7 (Data Storage), §10 (Periodic Evaluation), §17 (Archiving).

Deliverable

Technical assessment report — every Part 11 / Annex 11 clause scored against your AI system, with evidence cited.

Risk-prioritized remediation plan — ordered by inspection-finding likelihood × severity.

QGI decision-grade scorecard — Replayable / Signable / Defensible scoring for every AI workflow in scope.

Inspection-ready evidence pack — pre-formatted for the binders inspectors will actually open.

Who Books This

  • · QA managers deploying AI co-pilots in batch record review, deviation triage, or CAPA drafting
  • · Lab managers integrating AI into LIMS workflows (great pairing with our LIMSAI tool)
  • · IT / validation teams asked by their FDA / EMA-facing colleagues for an "AI Part 11 letter"
  • · Sponsors evaluating AI vendors for GxP fit-for-purpose claims

Reserve your Part 11 / Annex 11 assessment

Tell us about your AI system and where it sits in your QMS workflow. We'll scope within 24 hours.

Reserve a Discovery Call →