José Rodríguez-Pérez

Data Integrity and Compliance (eBook, PDF)

A Primer for Medical Product Manufacturers

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: ASQ Quality Press
• Seitenzahl: 279
• Erscheinungstermin: 8. Mai 2019
• Englisch
• ISBN-13: 9781951058470
• Artikelnr.: 66249718