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EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP, PDF eBook

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP PDF

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Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization.

Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is

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