21 CFR part 11 regulations focus on electronic records and electronic signatures. The regulation includes directives to allow companies to replace paper records with electronic records and handwritten signatures with electronic signatures. These electronic signatures must be treated as the equivalent to hand written signatures i.e. legally binding and irrefutable.
Executing an electronic signature in Riffyn requires:
- Reason for signing (such as 'approval', 'ownership', etc.)
The signature will implicitly be linked to an electronic record that constitutes the process/experiment being signed. In Riffyn, a process admin can set requirements for signing a process/experiment using the "Electronic Signatures" section of a process/experiment.