EU Annex 11 Insights

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.

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What other technologies are related to EU Annex 11?

EU Annex 11 Complementary Technologies

21 CFR Part 11

21 CFR Part 11 is a regulation that defines the requirements for electronic records and electronic signatures. EU Annex 11 also addresses electronic records and signatures within the EU, so they are complementary since companies doing business in both regions need to comply with both.

mentioned alongside EU Annex 11 in 5% (118) of relevant job posts

GAMP 5

GAMP 5 is a guideline for good automated manufacturing practice. Both EU Annex 11 and GAMP 5 address the validation of computerized systems, so GAMP provides guidance that can support Annex 11 compliance.

mentioned alongside EU Annex 11 in 4% (87) of relevant job posts

GAMP5

GAMP5 is a guideline for good automated manufacturing practice. Both EU Annex 11 and GAMP5 address the validation of computerized systems, so GAMP provides guidance that can support Annex 11 compliance.

mentioned alongside EU Annex 11 in 4% (69) of relevant job posts