Data Integrity and Compliance

Download or read book Data Integrity and Compliance written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2019-05-08 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.