ENGLISH

Data integrity in pharmaceutical and medical devices regulation operations: best practices ... guide to electronic records compliance

By Lopez , Orlando

Book information

Publisher
Productivity Press
Year
2017
ISBN
978-1-4987-7324-9, 1498773249
Language
english
Format
PDF
Filesize
4 MB (4570470 bytes)
Edition
1
Pages
394\394
Time added
2017-01-21 08:00:00

Description

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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