EU Annex 22 (AI in GMP) is the first regulatory annex that treats AI as a validated subsystem. That means the AI needs published governance, a benchmark that gates every release, safeguards on its outputs, a human-in-the-loop policy, a drift monitor and a documented fallback. Here is a working blueprint.
The six-part assurance stack
- Published governance — what the AI is used for, what it is not for.
- Benchmark set — the frozen, versioned reference that gates every release.
- Safeguards on outputs — checks that constrain what the AI can emit.
- Human-in-the-Loop reviews — humans in the loop where the risk demands it.
- Drift monitor — the tripwire and rollback plan when reality moves.
- Documented fallback — the workflow keeps working when the AI is off.
How GxP Copilot embodies the stack
GxP Copilot publishes its own AI governance, ships a working fallback for when the AI is unavailable, and enforces HITL through the Human-in-the-Loop reviews workflow. That is what "validates its own AI" means in practice — see Annex 22 assurance.
Delivered as a service
Our AI validation services team stands up the same stack for your AI systems: RAG pipelines, ML classifiers, agentic copilots, predictive maintenance, decision support.
The regulatory context
EU Annex 11 & Annex 22 readiness — including Annex 22 — is where the EMA is heading. FDA's AI/ML SaMD action plan is a parallel path in the US. If you are building AI for pharmaceuticals, biotechnology or medical devices, this is the assurance stack regulators will expect.
Where to go next
Explore GxP Copilot for AI-native validation, TraceDraft for source-traceable clinical documentation, or book a demo to see either on your own data.
