[5440]

I review software for at least 3-5 companies per week as part of FDA submission packages. The FDA requirements require traceability between reqs and the validation. While many small companies just use excel spreadsheets for traceability, the majority of large companies seem to use JIRA tickets alongside confluence. While those arent the only methods, they seem to be 90% of the packages I review.

[robertlagrant]

Health tech - we also use this combo. The Jira test management plugin XRay is pretty good if you need more traceability.

[rubidium]

Xray and R4J plugins make it pretty nice in JIRA... as far as traceability goes it's MUCH more user friendly than DOORS.

[scruple]

Exactly the same process for us, also in healthcare and medical devices.

[spaetzleesser]

I would love to see how other companies do it. I understand the need for traceability but the implementation in my company is just terrible. We have super expensive systems that are very tedious to use. The processes are slow and clunky. There must be a better way.

[gourneau]

We have been working software for FDA submissions as well. We use Jama https://www.jamasoftware.com/ for requirements management and traceability to test cases.

[sam_bristow]

I have also used Jama in a couple of companies. One for medical devices and one doing avionics. My experience is that it's quite similar to Jira in that if it's set up well it can work really well. If it's set up poorly it is a massive pain.

[jhirshman]

hi, we're trying to build a validated software environment for an ELN tool. I would be interested in learning more about your experience with this software review if you could spare a few minutes -- [e-mail]