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This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.If you want to discuss an alternative approach, contact the FDA staff responsible forimplementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

This guidance is intended to describe the Food and Drug Administration’s (FDA’s) currentthinking regarding the scope and application of part 11 of Title 21 of the Code of FederalRegulations; 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,havechosen 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 (thePHS 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 part11) are referred to in this guidance document as predicate rules.

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