Free White Paper - Managing Compliance with 21 CFR Part 11

Managing Compliance with 21 CFR Part 11 by Tom Heinricher, Sage ERP X3 Senior Business Consultant
• Title 21, Part 11 of the U.S. Food and Drug Administration’s (FDA) Code of Federal Regulations requires drug makers, medical device manufacturers, biotech companies, biologics developers and other FDA-regulated industries (except food manufacturers) to implement controls– including audits, validation systems and documentation – for software and systems involved in processing many forms of data as part of business operations and product development.
Also Included: Sage ERP X3 | Medical Devices & Pharmaceuticals
Addressing the Unique and Specialized Needs of Medical Device and Pharmaceutical Manufacturers
21 CFR Part 11
 
 
 
 
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