Compliance, Market Requirements, Standards for Jira Fields Capture Market Requirement by Segment

[KP11]

We will be putting in a several Projects Medical GOV etc and need to know if Jira has builtin plugins or packaged fields for Compliance, Market Requirements, Standards.
Specifically for Medical devices we would need a field Market Requirements for FDA. For GOV it owuld be DOD or IOS ISO9001-AS90100.
We really do not see FDA as a customer or compoenet or source. Since they will be sending requirements or standard for a device specification.
Are there any JIRA fields, process or flows recommended to create a project that is dependant or REQS from FDA DOD etc?

We eventually want to search a JIRA record to capture market requirement by segments: DOD FDA ETC

Also can you make a customer field project specific? Only ceratin customer would be listed for specific project? What area of doc?

[LUC FILION · Accepted solution]

KP-11,

You may be interested to take a look at our Gaia for JIRA package, which includes a "Starter Process template" intended to follow specific industry standards.

We do have created several configurations and customizing for supporting thoses standards (for instance IEC/ISO 62304). We also can use this solution for IEC/ISO 29110 for ISO obtaining certification. I believe we are close to what you need.

I suggest you first explore our add-on (which includes methods for supporting Requirements Management) following this link : http://bit.ly/RwwjGQ

If you have questions, I suggest you contact us directly.

Good luck,

Luc (luc.filion@nuumsolutions.com)

[Matteo Gubellini _SoftComply_]

Hi KP-11,

We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. 

https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview

It contains full guidance for FDA's 21 CFR compliance

Regards

Matteo

[Ellen Feaheny [AppFusions]]

Hi @KP11 -

AppFusions has this plugin addressing this FDA compliance use case for JIRA ... at least to THIS level (so far).

https://www.appfusions.com/display/PRT11J/Home

However, as you are alluding to and I would agree - the specs and requirements are large.

There's lots of interpretations on what meets the need or not, depending on org. We have a number of customers that use this plugin. Whether it meets your needs, is up to your discretion.

At the most general level - is JIRA a good workflow tool for this use case? I would argue yes, yet does require proper add-ons, configs, and possibly customizations, depending on the rigidity of your requirements.

Feel free to contact me off-line - happy to discuss this with you and ideas on how to get you there.

Ellen
ellen@appfusions.com

p.s.

Related threads - search for FDA:

https://answers.atlassian.com/questions/151613/confluence-for-fda-regulated-document-management