Computerized Systems Validation(CSV) of GitLab to support regulated activities

I am new to the forum. My name is Thomas, and I am a Regulatory Compliance consultant. I have been tasked with Validating GitLab for a client. This validation will focus on meeting SaMD regulations under ISO 13485, 21 CFR 820.30 Design Control and 21 CFR Part 11.

Has anyone else Validated GitLab for use in regulated space? If so, what approach did you use?

Thanks, and Be Well!

Hi, @TShoe.

I can’t be of much assistance but maybe having a look at the
compliance features and the FIPS compliance can give you an idea of where to start.

Good luck!