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Managing Compliance with 21 CFR Part 1

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.

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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 F....
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Addressing the Unique and Specialized Needs of Pharmaceutical Manufacturers
 

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