Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Data Integrity and Compliance: A Primer for Medical Product Manufacturers

Data Integrity and Compliance: A Primer for Medical Product Manufacturers

Rodríguez-Pérez, José

Hardcover

Business GeneralMedical ReferenceGeneral Computers

ISBN10: 0873899873
ISBN13: 9780873899871
Publisher: Asq Quality Pr
Published: May 8 2019
Pages: 274
Weight: 1.18
Height: 0.63 Width: 6.00 Depth: 9.00
Language: English
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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