Insights
Insights
Short articles on the questions QA, validation and IT leaders ask me most. Every regulatory claim points to the clause it comes from. Drafts are labeled as drafts.
Annex 11 revision and Annex 22: what is actually in the drafts
Seventeen sections instead of seventeen clauses, a new AI annex, and none of it in force yet. What to prepare now.
Read the article →Audit trail review: from sampling to full coverage without breaking Part 11
The regulation asks for review, not for reading every line. How review by exception scales, and where a human must still decide.
Read the article →CSA and CSV: what inspectors actually expect
Assurance commensurate with risk is not new. GAMP 5 second edition already says how to scale testing and documentation.
Read the article →Choosing an AI tool for a GxP process: four questions before the demo
Supplier maturity, model category, intended use, and the human control point. Ask them before the sales deck starts.
Read the article →Glossary
Working definitions as used on this site, each traced to the clause it comes from where a regulation defines the term.
See the glossary →Data Integrity self-check
Twelve yes/no questions on audit trails, access, e-signatures, backups, spreadsheets and periodic review. Score your system in five minutes.
Take the self-check →Want this applied to your systems?
Book a discovery call. We will map where manual review is costing you the most, and whether CSV/CSA, AI governance, or an AI tool assessment is the right place to start.