Data Integrity in Pharmaceutical and Medical Devices Regulation Operations

Best Practices Guide to Electronic Records Compliance

Nonfiction, Health & Well Being, Medical, Reference, Hospital Administration & Care, Medical Science, Pharmacology
Cover of the book Data Integrity in Pharmaceutical and Medical Devices Regulation Operations by Orlando Lopez, Taylor and Francis
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Author: Orlando Lopez ISBN: 9781315349978
Publisher: Taylor and Francis Publication: November 3, 2016
Imprint: Productivity Press Language: English
Author: Orlando Lopez
ISBN: 9781315349978
Publisher: Taylor and Francis
Publication: November 3, 2016
Imprint: Productivity Press
Language: English

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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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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