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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