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 of experience in the pharmaceutical and medical devices regulated operations 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. Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance covers the Good E-records Integrity Practices (GEIP) relevant to the Worldwide Health Agency GMP. It provides practical information to enable compliance with e-records integrity, while highlighting and efficiently integrating worldwide regulation into the subject. It is written in a practical way to fulfill the requirements on data integrity of the practitioners under any health agent, and it thoroughly examines the controls of computer systems in the good manufacturing practices environment. This book, relevant to production systems and quality control systems relevant to the manufacture of medicinal products, provides practical information to enable e-records requirements compliance to the e-records integrity regulatory expectations, while highlighting the e-records suitability implementation and associated risk-assessed controls, and e-records handling.

Book jacket.