Annex 11 Insights

What is Annex 11?

Annex 11 is part of the EU Good Manufacturing Practice (GMP) guidelines, specifically addressing computerized systems used in the pharmaceutical industry. It outlines requirements for the validation, data security, audit trails, and overall management of computerized systems to ensure data integrity and product quality. It is commonly used to guide the implementation and maintenance of systems used for manufacturing, testing, and storage of pharmaceutical products.

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What other technologies are related to Annex 11?

Annex 11 Complementary Technologies

21 CFR Part 11

21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Annex 11 is the EU equivalent, so understanding 21 CFR Part 11 is complementary.

mentioned alongside Annex 11 in 6% (151) of relevant job posts

Data Integrity

Data integrity principles are crucial for Annex 11 compliance. Annex 11 emphasizes the importance of ensuring data is complete, consistent, and accurate, which aligns directly with data integrity requirements.

mentioned alongside Annex 11 in 5% (55) of relevant job posts

GAMP 5

GAMP 5 provides guidance on good automated manufacturing practice and complements Annex 11 by offering a framework for validating computerized systems used in pharmaceutical manufacturing.

mentioned alongside Annex 11 in 3% (71) of relevant job posts