The topic of sofware validation for medical devices is not an easy step in setting up the QMS, there seems to be comparably little actual information available on how to go about things the “right” way. There’s some good lessons in your planning and reporting.

This addon aligns perfectly with the work my organization is doing with AAMI to help drive the acceptance and safety of modern technology in the regulated medical device space. Using automated validation means we don’t need to spend resource time on manually testing and keeping our Jira and Confluence tools in a validated state.

The extensive test cases and clear reports make validation a breeze. And if a test fails, the SoftComply team is there to help you promptly in figuring out what could be an issue. The setup does take some time, but nothing an experience Atlassian administrator can’t handle. I highly recommend this tool as it gives you automated weekly validation reports on a cloud system that might change without you noticing it.