Data Integrity in Pharmaceutical and Medical Devices Regulation Operations e-bog
288,10 DKK
(inkl. moms 360,12 DKK)
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, maintena...
E-bog
288,10 DKK
Forlag
Productivity Press
Udgivet
3 november 2016
Længde
372 sider
Genrer
Economics
Sprog
English
Format
epub
Beskyttelse
LCP
ISBN
9781315349978
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.