Guides
In-depth guides on Annex 11, Annex 22, ALCOA+ and related regulatory topics.
A guide explains a regulation in the terms of the work it governs. Ours cover EU GMP Annex 11 clause by clause with the draft revision and draft Annex 22 on artificial intelligence, and data integrity under ALCOA+ — what each attribute means in practice and where integrity actually breaks.
- guideEU Annex 11 & Annex 22 Guide (with revision preview)What Annex 11 requires today, what the revision changes, and how Annex 22 (AI in GMP) reshapes the assurance stack.Read it
- guideData Integrity (ALCOA+) GuideALCOA+ across GxP systems — with gap assessments, remediation patterns and a monitoring cadence that keeps it from drifting.Read it
Written against the clause, not around it
Regulatory summaries tend to restate the regulation in slightly different words, which helps nobody. These go clause by clause and say what the control looks like when it is working — and, where there is a known gap or a commonly skipped obligation, name it.
Periodic evaluation under Annex 11 clause 11 is the clearest example: it is required, it is routinely overdue, and almost nothing written about Annex 11 says so plainly.
Drafts labelled as drafts
The Annex 11 revision and Annex 22 went to consultation in 2025 and have not been adopted. We cite both as drafts every time they appear. Presenting a draft annex as a binding obligation is the fastest way to lose the trust of the people who would actually know.
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