Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance, Second Edition - Couverture rigide

 
9781420088946: Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance, Second Edition

Synopsis

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

À propos de l?auteur

Guy Wingate

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Autres éditions populaires du même titre

9781032917511: Pharmaceutical Computer Systems Validation

Edition présentée

ISBN 10 :  1032917512 ISBN 13 :  9781032917511
Editeur : CRC Press, 2024
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