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

Language: English

Published by Taylor & Francis Inc Apr 2015, 2015

1482243628 / 9781482243628

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Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH

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Neuware - Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program.The ideas presented in this book are based on the author's 25 years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functions. The book details a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly.Examining the implementation of the computer systems validation entirely based on EU Annex 11, the book includes examples from laboratory, clinical, and manufacturing computer systems. It also discusses electronic record integrity associated with stored information.…

Seller Inventory # 9781482243628

Title
EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
Author
Orlando Lopez
Publisher
Taylor & Francis Inc Apr 2015
Publication year
2015
Condition
Neu
Binding
Buch
Language
English
ISBN 10
1482243628
ISBN 13
9781482243628
Item weight
864 grams
Dimensions
261x185x26 mm

AHA-BUCH GmbH

Einbeck, Germany

5-star seller

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