[DOC-288] 21 CFR Part 11 Compliance

ElTimuro commented 12 months ago

Regulation Details: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
21 CFR Part 11 Compliance would allow Documenso to be used in medical use cases like trial, patient waivers, and the medical equipment industry
Since it's a complex regulation, support should be for self-hosted versions only in the beginning
Longterm, this will probably be supported by the hosted version as well
Features needed for this that are not part of any other use cases should be activatable by a "CFR21PART11_COMPLIANCE" feature flag

ivoflipse commented 4 months ago

Is there anything that can be done to help here?

ElTimuro commented 4 months ago

@ivoflipse currently not. We are developing this internally with Vial.com and will share details soon
We plan to publish the exact measures we took so others can learn from it
Once we publish, feedback is very welcome
You are free to look at the current repo, as we add all necessary features, but so far we don't have collection what belongs to 21 CFR

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