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.
Price: 135 AUD
Location: Hillsdale, NSW
End Time: 2024-12-04T06:42:17.000Z
Shipping Cost: 33.01 AUD
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Item must be returned within: 60 Days
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EAN: 9780873899871
UPC: 9780873899871
ISBN: 9780873899871
MPN: N/A
Format: Hardback, 274 pages
Author: American Society for Quality (Other)
Book Title: Data Integrity and Compliance: A Primer for Medica
Item Height: 1.6 cm
Item Length: 22.9 cm
Item Weight: 0.54 kg
Item Width: 15.2 cm
Language: Eng
Publisher: ASQ Quality Press
