Data Integrity and Compliance: A Primer for Medical Product Manufacturers (Hardcover) (ISBN-13: 9780873899871)

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.

Author: José Rodríguez-Pérez
ISBN-10: 0873899873
ISBN-13: 9780873899871
Publisher: ASQ Quality Press
Language: English
Published: 05/08/2019
Pages: 274
Format: Hardcover
Weight: 1.18lbs
Size: 9.00h x 6.00w x 0.63d