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Does "Part 11 Module Enabled" comply with QES (Qualified electronic signature) for EU or is there a need to use a different module? Thank you.
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Does "Part 11 Module Enabled" comply with QES (Qualified electronic signature) for EU?
+1- Newcomer
Best answer by mrave
21 CFR Part 11 in the US and QES in EU are two different things that can technically work together, but this is rather the exception than the rule.
By default a CFR Part 11 account only generated standard electronic signatures (SES) but in a specific format that complies with the regulation. In comparison QES is a signature type that works independently.
There are different modules in Docusign eSignature that allow to create a qualified electronic signature (QES) through various different processes and in cooperation with different Trust Service Providers (TSP).
+14- Docusign Employee
- 929 replies
- Answer
21 CFR Part 11 in the US and QES in EU are two different things that can technically work together, but this is rather the exception than the rule.
By default a CFR Part 11 account only generated standard electronic signatures (SES) but in a specific format that complies with the regulation. In comparison QES is a signature type that works independently.
There are different modules in Docusign eSignature that allow to create a qualified electronic signature (QES) through various different processes and in cooperation with different Trust Service Providers (TSP).
+14- Community Moderator
- 2763 replies
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