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What Is 21 Cfr Part 11 ? |
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Answer» Title 21 CFR PART 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, DEFINES the criteria under which electronic records and electronic signatures are CONSIDERED to be trustworthy, reliable and equivalent to paper records. Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. |
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