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.

chapter 1|4 pages


chapter 2|34 pages

Inspection Trends

chapter 3|8 pages

Electronic Records Life Cycle

chapter 4|12 pages

Electronic Records Related Definitions

chapter 6|14 pages

Electronic Records Handling: EMA Annex 11

chapter 8|20 pages

Trustworthy Computer Systems

chapter 9|12 pages

MHRA Guidance

chapter 10|10 pages

Electronic Records Governance

chapter 11|14 pages

Procedural Controls for Handling E-Records

chapter 17|8 pages

Electronic Records and Cloud Computing

chapter 18|6 pages


chapter 19|6 pages

Electronic Records Remediation Project

chapter 20|6 pages