Data Integrity and Compliance (eBook)

A Primer for Medical Product Manufacturers

Jose Rodriguez-Perez (Autor)

eBook Download: PDF

2019
279 Seiten
Asq Quality Press (Verlag)
978-1-951058-47-0 (ISBN)

Infos

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.

Produkt-Details

• Erscheint lt. Verlag: 8.5.2019
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Pflege
• Themenwelt: Medizin / Pharmazie ► Pharmazie ► PTA / PKA
• Themenwelt: Wirtschaft ► Betriebswirtschaft / Management ► Logistik / Produktion
• Schlagworte: data integrity, data compliance, medical products, medical devices, healthcare, medical devices manufacturing, medical products manufacturing
• ISBN-10: 1-951058-47-X / 195105847X
• ISBN-13: 978-1-951058-47-0 / 9781951058470