Add FDA 21 CFR Part 11 Compliance, PLEASE!

Feature requests
, ,
1

Hi, it would be absolutely incredible to have 21 CRF Part 11 compliance! We currently use Monday for a lot of our trackers/systems, but will eventually need to start using an eQMS in order to ensure data integrity :frowning: I would love to see a plan for this kind of compliance in the pipeline, since we absolutely love using Monday and would hate to have to transition away from it. I’ve included the link to the FDA’s guidance below! If anyone knows of any workarounds that their company has used to adjust Monday for Part 11 or other ways to do so, please let me know!

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application#iiia

2

Hi @astedtler, did you find a solution for this? I have a few ideas and want to see if you want to brainstorm on this.