Deploy AI in regulated processes, and survive the audit.
Life-sciences teams are putting AI into GxP-regulated work, manufacturing and QC, pharmacovigilance, quality-document drafting, clinical operations, submissions, faster than their quality systems can absorb it. A general ISO/IEC 42001 program does not, by itself, answer a 21 CFR Part 11 audit-trail question or an ICH Q10 change-control expectation. We close that gap.
What we map your AI against
21 CFR Part 11
Audit trail, access control, secure e-signatures, and record-to-signature linking on any AI output that becomes a GxP record.
FDA Computer Software Assurance
Final since September 2025: risk-based, intended-use-driven assurance for AI used in production and quality systems. Least burdensome, by design.
ICH Q10
Management responsibility, performance monitoring, CAPA and change control across the lifecycle.
ALCOA+ data integrity
The floor for the data your AI trains and runs on, and the records it produces.
We also read your system against the FDA’s January 2025 draft AI guidance for devices and for drug and biologic development, and the January 2026 FDA / EMA guiding principles. The drafts are not law and we say so on the face of every report; the direction of travel is not in doubt.
An overlay, not a second system
This is a layer on top of the AI controls you already run under ISO/IEC 42001 or the NIST AI RMF, not a parallel program. We take each control you have, map it to the GxP requirement it must now satisfy, and show exactly what additional evidence an FDA-facing buyer or investigator expects. Intended use and patient-safety or product-quality risk set the depth; there is no one-size validation script.
| Add-on | What it adds | Indicative uplift |
|---|---|---|
| GxP Readiness Checklist | Self-scored Part 11 / CSA / ICH Q10 checklist. Ask for it on the triage call. | Free |
| GxP Readiness Overlay | Part 11 / CSA / ICH Q10 readiness scored over an AI Deployment Gate or a Readiness Snapshot. | +$6,000–$10,000 |
| GxP Gap Assessment | Full control-map assessment against the GxP overlay, with a sequenced remediation roadmap. | +$15,000–$30,000 |
| Validation package review | Independent review of a CSA-aligned validation package your team or vendor has written. We review; we do not author. | Project-based |
Why Sentinel for GxP
We already live under a quality system
Our principals run an ISO/IEC 17025-accredited, DEA-registered laboratory. Chain of custody, data integrity and inspection discipline are our native environment, not a slide.
Risk-based, not box-ticking
CSA’s least-burdensome philosophy is how we work: effort follows patient-safety and product-quality risk.
Inspection-ready deliverables
A control map and evidence index you can hand straight to a validation lead or an FDA investigator.
Independent by design
We assess what you and your vendors built. We do not build it, so our finding is worth something when the investigator asks who checked.
Scope note
Overlay on the Sentinel AI control set; methodology in SG-OVL-LS-01. Maps to 21 CFR Part 11, FDA CSA (final 2025) and ICH Q10. FDA AI guidance cited is draft and not law. We do not issue certifications and nothing on this page is regulatory or legal advice.
Find out where you stand.
Free, 30 minutes, no deck.
The AI Risk Exposure call: we walk your AI footprint, flag your likely obligations, and tell you plainly whether and where you need help.
Book the call →