Annex 15 and its 6 linked instruments

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Details: Guide Definitions: every term and label explained

	Annex 15	Annex 11 (2011)	ICH Q9(R1)	ICH Q10	Annex 11 revision	MHRA GxP data integrity	PIC/S PI 006-4
Authority	European Commission	European Commission	ICH	ICH	European Commission	MHRA	PIC/S
Legal weight	GMP guide & annexes	GMP guide & annexes	Guidance & Q&A	Guidance & Q&A	GMP guide & annexes	Guidance & Q&A	Guidance & Q&A
Status	In force	In force	Final	Final	Draft	Final	Final
Last verified	Not yet	Not yet	Not yet	Not yet	Not yet	Not yet	Not yet
Summary	The EU GMP annex on qualification and validation.	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.	The international guideline on quality risk management. It is the basis for scaling validation effort to risk in Annex 11, Annex 22 and computer software assurance, and the 2023 revision addresses subjectivity, formality and risk-based decision-making.	ICH model for an effective quality management system for the pharmaceutical industry.	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.	UK guidance and definitions for data integrity across GxP areas, including data governance, ALCOA+, audit trails and computerised system controls.	PIC/S recommendations on qualification and validation, updating PI 006-3 of 2007. Link only.
Lifecycle	1 Oct 2015 Came into operation	~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011) 30 Jun 2011 Came into operation	9 Nov 2005 Original Q9 reached Step 4 18 Nov 2021 Q9(R1) released for public consultation at Step 2 18 Jan 2023 Reached Step 4 (final)	8 Apr 2009 Published by FDA as guidance	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)	23 Jan 2015 Earlier GMP data integrity definitions and guidance first published 13 Mar 2015 Earlier GMP guidance updated with clarifications 9 Mar 2018 Published 4 Apr 2018 Earlier GMP guidance withdrawn, replaced by this GxP guidance	1 Oct 2026 Version PI 006-4 dated 1 Oct 2026
Source	Official text Source: European Commission. Licensed under CC BY 4.0.	Official text Source: European Commission. Licensed under CC BY 4.0.	Official text Source: ICH.	Official text Source: ICH.	Official text Source: European Commission. Licensed under CC BY 4.0.	Official text Source: MHRA. Contains public sector information licensed under the Open Government Licence v3.0.	Official text Summary in our own words. See the official text from PIC/S.

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