Data Integrity and Compliance: A Primer for Medical Product Manufacturers

Very comprehensive book, in which the author in addition to describing Data Integrity principles and guides, links the DI principles to the cGMPs regulations and uses real example of DI violations and their consequences.The book includes a lot of useful recommendations on how to prevent data integrity problems, and provides guidance for auditing DI principles, making this book a very solid reference for pharma and medical devices professionals.The book is really showing how to integrate Data Integrity Principles into the Quality Systems!

The 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.