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Annex 11

Annex 11

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**Annex 11**

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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