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Validating Corporate Computer Systems

Validating Corporate Computer Systems

Guy Wingate

123,01 €
IVA incluido
Disponible
Editorial:
Taylor & Francis Ltd
Año de edición:
2019
Materia
Química
ISBN:
9780367398569
123,01 €
IVA incluido
Disponible

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Sobre IBD

Written by experts, this book provides authoritative information and practical advice on validating corporate computer systems. It covers good IT practice and validation principles and presents case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include the increasing role of IT systems within the modern pharmaceutical manufacturing plant and the move toward paperless manufacturing, how to develop an information strategy, the importance of demonstrating regulatory compliance, how to maintain validated systems, conduct supplier audits for software packages, hardware manufacturers, and software integrators, the practical implications of 21 CFR 11, and more.

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Otros libros del autor

  • Pharmaceutical Computer Systems Validation
    Guy Wingate
    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,...
  • Validating Corporate Computer Systems
    Guy Wingate
    One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. ...