EU Annex 11 Guide to Computer Validation Compliance for the...

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EU Annex 11 Guide to Computer...

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Name: EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
ISBN: 9781482243628

Orlando Lopez

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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.

种类:

Medicine

年:

2015

出版社:

CRC Press

语言:

english

页:

280

ISBN 10:

1482243628