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?
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.
Hi @KP11 -
AppFusions has this plugin addressing this FDA compliance use case for JIRA ... at least to THIS level (so far).
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.
Related threads - search for FDA:
We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices.
It contains full guidance for FDA's 21 CFR compliance
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