Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application

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 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.

Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the 29 PHS Act), even if such records are not specifically identified in Agency regulations (§ 11.1).

The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 31 11) are referred to in this guidance document as predicate rules.

FDA