Publisher: CRC Press
Year of Publication: 2016
Author(s) : Orlando Lopez
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 the US Department of Defence and 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.
This book has been written in a practical way to fulfill the requirements on data integrity of the practitioners under any health agency. It examines the controls of computer systems in the good manufacturing practices environment, includes case studies as well as provides a practical approach to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.