EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP (by Orlando Lopez)


Author(s): Orlando Lopez

Publisher: CRC Press
Publish date: 2015-03-16
ISBN-10: 1482243628
ISBN-13: 9781482243628
Language: English
Description:
This book provides practical information to enable compliance
with computer system validation requirements, while highlighting
and integrating the Annex 11 guidelines into the computer
validation program. The ideas presented in the book are based the
author’s experience in the US Department of Defense and regulated
industries in various computer systems development, maintenance,
and quality functions. A practical approach is presented to
increase efficiency and to ensure that software development and
maintenance is achieved correctly.

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