EU GMP Annex 11 revision: Computerised Systems (draft)

European Commission · Draft

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Summary

A full rewrite of Annex 11, published for consultation with the revised Chapter 4 and the new Annex 22. It expands expectations on supplier oversight, data integrity, audit trails, identity and access, cloud and outsourced services. Not yet in force: the 2011 Annex 11 still applies.

Dated events

1. Target 31 Dec 2026 Target: final text to European Commission (Q4 2026, slipped from Q1 2026) Source for Target: final text to European Commission (Q4 2026, slipped from Q1 2026)
2. 7 Oct 2025 Public consultation closed Source for Public consultation closed
3. 7 Jul 2025 Draft published for public consultation Source for Draft published for public consultation

Official source

Official text

Source: European Commission. Licensed under CC BY 4.0.