Data Integrity in Pharmaceutical and Medical Devices Regulation Operations

Download or read book Data Integrity in Pharmaceutical and Medical Devices Regulation Operations written by Orlando Lopez and published by CRC Press. This book was released on 2016-11-03 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.