Annex 11 (2011) and its 6 linked instruments

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.

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 chapter on documentation. Manufacturers of medicinal products must define their documents and media in the quality management system, on paper, electronically or as photographs, and keep them accurate, intact, available and legible. Revision 1 updated the sections on generating, controlling and retaining documents because of growing electronic use.

The PIC/S GMP guide used by participating inspectorates, including an annex on computerised systems equivalent to EU Annex 11. PIC/S co-drafts the current EU revisions.

EMA questions and answers on applying EU GMP. The Annex 11 section covers spreadsheets, database security, validation and storage of electronic data. The data integrity section covers data risk, the data lifecycle, audit trails, review of electronic data, ALCOA and supply chains.

The EU GMP annex on qualification and validation.

UK guidance and definitions for data integrity across GxP areas, including data governance, ALCOA+, audit trails and computerised system controls.

• ~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011)
• 30 Jun 2011 Came into operation

• 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

• 23 Sep 2026 PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17

• ~1 Feb 2011 Annex 11 questions dated February 2011

• 1 Oct 2015 Came into operation

• 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