Annex 11 Compliance — Complete Guide
EudraLex Annex 11 and FDA 21 CFR Part 11: requirements, differences, audit trail, electronic records, and data integrity for computerised systems in pharmaceutical GxP environments.
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Annex 11 Compliance — Guida Completa
EudraLex Annex 11 e FDA 21 CFR Part 11: requisiti, differenze, audit trail, electronic records e data integrity per sistemi informatici in ambienti GxP farmaceutici.
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Complete Guide to Computer System Validation
Methodology, regulatory frameworks and best practices for computerised system validation in GxP environments: GAMP 5 Second Edition, EudraLex Annex 11, FDA 21 CFR Part 11.
Leggi di più Guida Completa alla Computer System Validation
Metodologia, framework normativi e best practice per la validazione di sistemi informatici in ambienti GxP: GAMP 5 Second Edition, EudraLex Annex 11, FDA 21 CFR Part 11.
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