2

I would like to know what is the best way to implement a digital signature to achive Non-Repudation to acomplish 21-CFR-Part11-SubpartC-11.100.part-c. Anybody has implemented this for 21 CFR 11?

Non repudiation means that if a users sign the document. For him is impossible to say that he didn't sign that document. It should be equivalent to handwritten signature. see-here-for-more-info

1

Note that the problem is more of a legal than technical/implementation issue. Your links above to the FDA regulations and the other stackoverflow question How to achieve non-repudiation? emphasizes the legal aspect of it as well.

That means you will need to ensure compliance to laws of each country (e.g. ESIGN Act in the US). What is interesting about ESIGN is that it preserves the right of a person to NOT use electronic signatures. Might I suggest using a service such as https://www.docusign.com/ instead - see its section on legality.

Your Answer

By clicking “Post Your Answer”, you agree to our terms of service, privacy policy and cookie policy

Not the answer you're looking for? Browse other questions tagged or ask your own question.