What addons are best for FDA compliance?

SteveR

We are doing development that is considered to be a medical device and falls under FDA guidelines and requirements. They require things like traceability (tying requirements to pieces of code to specific tests to bugs, etc.), electronic signatures/approvals, robust change and version mgmt, etc. Looking for advice on what tools/addons are best.

Thanks,

Steve Rohde

JohnA_xb3t2l

Hi Steve,

If I'm honest this will be more about implementation of your systems rather than addons that will help you to implement them, so the first thing is to consider your needs and imagine them in terms of a workflow and integration between the applications. Whilst their are addons that will facilitate the process of implementing that workflow, but you need to think about exactly what you want/need to achieve because the Atlassian Stack in its present form will do virtually everything you need and it's just a case of being clear in what you need to implement. Often implementing a stack is a big challenge and developing processes for departmental changes require some advice from outside professionals to smooth the transition, so you might find that instead of purchasing addons you find better value just purchasing implementation and training services from an Atlassian Expert as they can assit you in getting the most out of the Stack and ensuring you meet all your compliance requiremnets.

All the best,
John