21 CFR PART 11

Electronic Records, Electronic Signatures.

Part 11 sets forth the criteria under which the Food and Drug Administration (FDA) considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

21 CFR Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in FDA regulations. It also applies to electronic records submitted to the FDA under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.

Electronic records that meet the requirements of Part 11 may be used in lieu of paper records, in accordance with 11.2, unless paper records are specifically required.

Computer systems (including hardware and software), controls, and attendant documentation maintained under this part 11, shall be readily available for, and subject to, FDA inspection.

This is only a brief extract; the original document from which the above was taken can be found at FDA.gov

This is only an overview/extract of the standard. Users should not rely on its accuracy, but should refer to the complete standard of the appropriate revision.