Validation of Bitbucket for use in safety-critical development

GlenLarson

For use in a safety-critical medical device, the tools that affect product development need to be valid for their use. This includes the revision control system and issue tracking system.

We're using git with Bitbucket and the Bitbucket issue tracker for an FDA Class IIb device with software that is Class C per IEC 62304.

Are there any validation reports available from Atlassian for these tools? Are there any test protocols available to help us test them ourselves?

JimmyVanAU

Hi Glen,

While I don't have any direct documentation, you might like to post this question in the Life Sciences group to see if anyone can help there:

https://community.atlassian.com/t5/Life-Sciences/ct-p/life-sciences

I can see on community a lot of chatter about e-signatures and document sign off (https://community.atlassian.com/t5/Confluence-questions/Confluence-for-FDA-Regulated-Document-Management/qaq-p/78273, https://www.midori-global.com/blog/2018/05/22/creating-complete-and-accurate-records-for-fda-inspections-from-jira, https://softcomply.com/must-have-apps-on-atlassian/ and https://www.slideshare.net/GoAtlassian/innovation-regulation-how-eli-lilly-customizes-atlassian-to-find-the-balance), but I can't see anything related to your particular issue or any validation test reports. I think raising a support ticket with Atlassian directly would be your best bet.