EU GMP Annex 11: Computerised Systems (2011)

European Commission · In force

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Summary

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.

Dated events

1. 29 Sep 2026 Checked: still the version in EudraLex Vol 4 Source for Checked: still the version in EudraLex Vol 4
2. 30 Jun 2011 Came into operation Source for Came into operation

Official source

Official text

Source: European Commission. Licensed under CC BY 4.0.