2024年10月1日 · 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.

FDA forms (e.g., 1571, 356h) and documents require a signature. Accepted signature methods by FDA are: Scanned signatures; Digital signatures; Flattened digital signatures.

Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

2024年10月2日 · The guidance provides recommendations regarding the requirements in our regulations, pursuant to which FDA considers electronic systems, electronic records, and electronic signatures to be...

Information on where to submit the certification can be found on FDA's web page on Letters of Non-Repudiation Agreement. (2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.

2025年1月6日 · What does 21 CFR Part 11 require for electronic signatures? The FDA allows electronic signatures to be used in place of pen and ink signatures on paper documents so that business can be conducted digitally. In order to be compliant electronic signatures must include: The printed name of the signer. The date and time the signature was executed

2024年10月2日 · The guidance provides recommendations regarding the requirements in our regulations, pursuant to which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

2024年10月24日 · Learn everything you need to know about 21 CFR Part 11 compliance, including electronic signatures, electronic records, and implementation requirements for FDA-regulated industries.

Title 21 CFR Part 11 brings FDA regulations into the digital age by allowing electronic documents and signatures on official government business. This affects industries regulated by the FDA, including: The use of digital signatures and electronic documents helps to speed up processes and simplify the approval of new products.

2016年4月8日 · Learn the key takeaways from FDA’s 21 CFR Part 11, including electronic records and signatures, validating electronic records, and more.