EU Annex 11 is part of the European Union Good Manufacturing Practice framework that addresses computerized systems used in regulated pharmaceutical manufacturing and related quality activities. It commonly refers to expectations for how such systems are specified, validated, controlled, secured, operated, and maintained when they support GMP-relevant processes or records.
In manufacturing and quality systems, EU Annex 11 is often discussed in connection with MES, LIMS, QMS, ERP, electronic batch records, electronic signatures, audit trails, access control, backup and recovery, data integrity, and supplier-managed systems. Its focus is not the software product alone, but the controlled use of computerized systems within a regulated process.
EU Annex 11 is often compared with 21 CFR Part 11, but they are not the same requirement set. Part 11 is a U.S. regulation focused on electronic records and electronic signatures, while EU Annex 11 is EU GMP guidance for computerized systems more broadly. In practice, organizations may consider both when the same system supports records, approvals, deviations, nonconformance records, or other quality-critical workflows across markets.