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ASQ Quality Press Data Integrity and Compliance: A Primer for Medical Product Manufacturers

Name: Data Integrity and Compliance: A Primer for Medical Product Manufacturers
Brand: ASQ Quality Press
Price: 48.0 GBP
Availability: InStock

Quality Assurance & Total Quality Management

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Description

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.

Product Specifications

Brand: ASQ Quality Press
Format: hardcover
ASIN: 0873899873
Category: Books > Subjects > Business, Finance & Law > Management > Quality Assurance & Total Quality Management
Domain: Amazon UK
Release Date: 08 May 2019
Listed Since: 26 June 2019

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ASQ Quality Press Data Integrity and Compliance: A Primer for Medical Product Manufacturers

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