Data Integrity and Compliance: A Primer for Medical Product Manufacturers
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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.
Format:Hardcover
Language:English
ISBN:0873899873
ISBN13:9780873899871
Release Date:May 2019
Publisher:ASQ Quality Press
Length:274 Pages
Weight:1.18 lbs.
Dimensions:0.6" x 6.0" x 9.0"
Related Subjects
Business Business & Investing Computers Computers & Technology Economics Medical Medical BooksCustomer Reviews
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