21 cfr part 11 guidelines for pharmaceuticals

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(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). 2. 20. 21. This document provides guidance to persons who, in fulfillment of a Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA)(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten