Glossary · GxP: good practices
EU GMP Annex 11 (computerized systems)
Also known as: Annex 11, EU GMP Annex 11, Computerised Systems (Annex 11)
EU GMP Annex 11 is the annex of EudraLex Volume 4 that applies to all computerized systems used as part of GMP-regulated activities. It requires that such systems be validated and that their use does not reduce product quality, process control or quality assurance compared with a manual system, with risk management applied throughout the lifecycle. The version in force dates from 2011.
- GxP
- Pharma
- EU
- Data integrity
In one sentence
EU GMP Annex 11 (2011) sets requirements for computerized systems in GMP: validation, data, audit trails, security and change control.
Example
A manufacturer introducing an electronic batch record system validates it, restricts access by role, reviews audit trails as part of batch review, and tests backup and restore before go-live.
How it applies
- Topics: The 2011 annex covers risk management, personnel, suppliers and service providers, validation, data, accuracy checks, data storage, printouts, audit trails, change and configuration management, periodic evaluation, security, incident management, electronic signatures, batch release, business continuity and archiving.
- Suppliers: Where suppliers provide or support systems, formal agreements must define responsibilities; the regulated company remains accountable.
- Data integrity: Audit trails, access control and electronic signatures are the technical basis for data integrity in electronic GMP records.
- Revision: In July 2025 the Commission, EMA and PIC/S published a revised Annex 11 for consultation, together with a new Annex 22 on artificial intelligence. Check whether the final version has been adopted; until then the 2011 text applies.
- Technical documentation: Validation documents, an up-to-date system inventory, configuration records, periodic review reports and incident records show that the system remains in a validated state.
Annex 11 vs. 21 CFR Part 11
21 CFR Part 11 is a US regulation focused on when electronic records and signatures are trustworthy equivalents of paper. Annex 11 is broader: it covers the whole lifecycle of computerized systems in GMP, including suppliers, periodic evaluation and business continuity. Companies serving both markets usually design one approach that meets both.