Free readiness check
Annex 22 Readiness Check for Labs
14 questions to assess in 20 minutes where your lab stands on AI in the GxP environment. Designed for QA, QC, validation and IT, regardless of what the final Annex 22 looks like.
PDF, 4 pages, A4, free, right after you submit.
Annex 22 is available as a draft (as of 5 October 2026). This content is not legal, regulatory or compliance advice.
Benefits
What the check gives you.
- 01Your status in 20 minutes14 questions in four blocks, each answered yes, partly or no. No prior knowledge of Annex 22 needed.
- 02Independent of the final textThe questions target what holds in any case: overview, responsibility, traceability.
- 03With an evaluationA short evaluation shows whether to start with organisation or with systems.
- 04For the whole teamDesigned as a worksheet for QC, QA, validation and IT, and usable in a workshop.
Preview
The questions at a glance.
For each question, you tick yes, partly or no. The PDF includes an evaluation.
Block A
Overview
- Do we have a list of all AI applications in the lab, including unofficial ones (e.g. chat assistants)?
- and 2 more questions in the PDF
Block B
Model and data
- Do we know whether a model is static or learning, and whether its results are reproducible?
- and 3 more questions in the PDF
Block C
People and responsibility
- Is it defined who checks AI results before they feed into a decision?
- and 2 more questions in the PDF
Block D
Systems and data sovereignty
- Is every processing step traceable (audit trail)?
- and 3 more questions in the PDF
Context
EU GMP Annex 22 is the first GMP text to address AI. The draft was opened for consultation in July 2025 together with the revised Chapter 4 and Annex 11, is currently being revised and is not in force.
The draft covers static models with deterministic outputs. Generative AI and LLMs should not be used in critical GMP applications; since its expert workshop in July 2026, the EMA has been examining a risk-based approach with guardrails.
Where AI is used, checking the outputs is key, for example through a human in the loop. This check shows where your lab stands in 20 minutes, regardless of what the final text looks like.
We use your details to provide the Readiness Check. No automated contact by sales or newsletter follows from it.
Read on
Go deeper on AI in the GxP lab.
CovaSyn is a tool for research and the lab, not validated GMP software and not compliance advice.