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Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
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Data Integrity in Pharmaceutical and Medical Devices Regulation Operations : Best Practices Guide to Electronic Records Compliance

Book Details

Format Hardback or Cased Book
ISBN-10 1498773249
ISBN-13 9781498773249
Publisher Taylor & Francis Inc
Imprint Productivity Press
Country of Manufacture GB
Country of Publication GB
Publication Date Oct 21st, 2016
Print length 372 Pages
Weight 904 grams
Dimensions 18.50 x 26.30 x 2.70 cms
Ksh 26,100.00
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Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.


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