Answer»
- Criteria under which electronic records and signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
- part APPLIES to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in AGENCY regulations. This part ALSO applies to electronic records submitted to the agency 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 this part 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 shall bereadily available for, and subject to, FDA inspection
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