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The EC has announced a new revision of EU GMP Annex 11 Computerised Systems. There are also associated changes to EU GMP Chapter 4 Documentation. Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these systems. The Annex defines EU requirements for computerised systems, and applies to all forms of computerised systems used as part of GMP regulated activities. This is a major revision, which has a significant impact on all GMP regulated companies. Significant aspects include revised and enhanced requirements covering quality risk management, system inventory, supplier assessment, periodic evaluation, and many topics covering system operation.
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