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Data Integrity and Compliance: A Primer for Medical Product Manufacturers
Rodríguez-Pérez, José (Author)
·
ASQ Quality Press
· Hardcover
Data Integrity and Compliance: A Primer for Medical Product Manufacturers - Rodríguez-Pérez, José
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Origin: U.S.A.
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Synopsis "Data Integrity and Compliance: A Primer for Medical Product Manufacturers"
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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All books in our catalog are Original.
The book is written in English.
The binding of this edition is Hardcover.
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