What is 21 CFR Pharma

 The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.

21 CFR Part 11 is the FDA's regulations for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company's quality management system.

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