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2008-04-01
GAMP 5: A Risk-based Approach to Compliant Gxp Computerized Systems - de Ispe Headquarters (Author)
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Le Titre Du Fichier | GAMP 5: A Risk-based Approach to Compliant Gxp Computerized Systems |
Date de Lancement | 2008-04-01 |
Traducteur | Karmanjot Roda |
Quantité de Pages | 476 Pages |
La taille du fichier | 22.34 MB |
Langue du Livre | Anglais et Français |
Éditeur | Carlton Books UK |
ISBN-10 | 2975105697-FYV |
Type de Livre | ePub AMZ PDF DITA PDAX |
de (Auteur) | Ispe Headquarters |
EAN | 629-9823326334-JLF |
Nom de Fichier | GAMP-5-A-Risk-based-Approach-to-Compliant-Gxp-Computerized-Systems.pdf |
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GAMP 5 A Riskbased Approach to Compliant Gxp Computerized Systems de Ispe Headquarters sur ISBN 10 1931879613 ISBN 13 9781931879613 Ispe Headquarters 2008 Couverture souple
La directive GAMP la plus récente version 5 – RiskBased Approach to Compliant GxP Computerized Systems – contient les derniers concepts et développements dans l’industrie ainsi que les idées les plus récentes des instances de régulation pour la réalisation des contrôles et validations Parmi les principales tendances citons notamment la Process Analytical Technology PAT et
Achieving Maintaining GAMP 5 Compliance RiskBased Approach to Software Development Verification 1 March 2017 Given the growing level of automation validation of computerized systems must be an integral part of projects to guarantee the quality of products and process controls
Ten years after its publication the ISPE GAMP® 5 Guide A RiskBased Approach to Compliant GxP Computerized Systems is regarded as the
A RiskBased Approach to Compliant Electronic Records and Signatures EN A RiskBased Approach to GxP Compliant Laboratory Computerized Systems Deuxième édition EN A RiskBased Approach to GxP Process Control Systems GPCS Deuxième édition EN
5 GAMP® Good Practice Guide A RiskBased Approach toCompliant Electronic Records and Signatures 327 329 6 GAMP® Good Practice Guide Validation of LaboratoryComputerized Systems 327 329 7 GAMP® Good Practice Guide IT Infrastructure Control andCompliance 328 330