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FDA Guidance: Electronic Records and Electronic Signatures

This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11.

Creator Organization	University of Virginia
Categories	CONDUCT > DATA MANAGEMENT > Data Storage CONDUCT > DATA MANAGEMENT > Data Capture
Website	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

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