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Changes and deletions of GMP-relevant data must be logged in the audit trail. Which events must be recorded in the audit trail and who determines which data is relevant for the audit trail?

On 07 July 2025, the EU Commission published 3 drafts of the EU GMP Guidance Annex 11 “Computerised Systems”, the new Annex 22 “Artificial Intelligence” and Chapter 4 “Documentation”. Here is an initial analysis of the Annex 11 draft.

The chapter "<1029> Good Documentation Guidelines and Data Integrity" has been published for comment on the website of the USP Pharmacopeial Forum since the beginning of July 2025. Comments and remarks on this draft, which is based on the previous version "<1029> Good Documentation Guidelines" from May 2018, can be submitted until September 30, 2025.

The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators. Although primarily used internally by FDA staff, it is available publicly. The Manual has now been revised.