EU Annex 11
**EU Annex 11**
What is EU Annex 11?
EU Annex 11 is part of the Good Manufacturing Practice (GMP) guidelines for medicinal products in the European Union. It specifically addresses computerized systems. Annex 11 outlines the requirements for the validation, data integrity, security, and audit trails of computerized systems used in pharmaceutical manufacturing, quality control, and storage. Its purpose is to ensure that these systems are reliable, accurate, and consistently perform as intended, ultimately guaranteeing the quality and safety of medicinal products.
What other technologies are related to EU Annex 11?
EU Annex 11 Complementary Technologies
Which job functions commonly mention EU Annex 11?
Which organizations are mentioning EU Annex 11?
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