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.
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.
This comprehensive guide for those with little or no legal knowledge provides detailed analysis of current data protection laws. It enables the reader to operationalise a truly risk-based approach to...
Studienarbeit aus dem Jahr 2017 im Fachbereich BWL - Unternehmensethik, Wirtschaftsethik, Note: 1,0, AKAD University, ehem. AKAD Fachhochschule Stuttgart, Sprache: Deutsch, Abstract: Jedes Jahr gibt...
The Yearbook 2021 for Global Ethics, Compliance & Integrity offers an upto-date overview of the recent and most significant developments in the interdisciplinary area of organizational Ethics,...
The United States Air Force's Center for Strategy and Technology was established at the Air War College in 1996. Its purpose is to engage in long-term strategic...
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