Data Integrity and Compliance
A Primer for Medical Product Manufacturers
José Rodríguez-Pérez
- 279 pages
- English
- PDF
- Available on iOS & Android
Data Integrity and Compliance
A Primer for Medical Product Manufacturers
José Rodríguez-Pérez
About This Book
Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial.The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.