Compare Annex 11 revision and Annex 11 (2011)

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How they are linked

Annex 11 revision will replace Annex 11 (2011) · Source Unverified link

Clause crosswalk: EU GMP Annex 11 (2011) ↔ Annex 11 revision (draft)

Side by side

	Annex 11 revision	Annex 11 (2011)
Authority	European Commission	European Commission
Legal weight	GMP guide & annexes	GMP guide & annexes
Status	Draft	In force
Last verified	Not yet	Not yet
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.	The current EU GMP annex for computerised systems used in GMP-regulated activities. It covers risk management, validation, data, audit trails, security, electronic signatures, periodic evaluation and business continuity. It stays in force until the revised Annex 11 is published and comes into operation.
Lifecycle	16 Nov 2022 Concept paper on revising Annex 11 (EMA/INS/GMP/778340/2022) 7 Jul 2025 Draft published for public consultation 7 Oct 2025 Public consultation closed Target 31 Dec 2026 Target: final text to European Commission (Q4 2026, slipped from Q1 2026)	~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011) 30 Jun 2011 Came into operation
Source	Official text Source: European Commission. Licensed under CC BY 4.0.	Official text Source: European Commission. Licensed under CC BY 4.0.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.