nav[aria-label="Primary Navigation"] { padding: 0; & ul { list-style: none; width: 100%; display: flex; flex-direction: row; justify-content: start; align-items: start; gap: 30px; padding: 0; & li { margin: 0; } & ul li { list-style: none; } } }

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?

Accepted answers

LUC FILION_ybz8ol

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)

All comments

Ellen Feaheny [

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

LUC FILION_ybz8ol

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.

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

Welcome!

It looks like you're new here. Sign in or register to get started.

Quick Links

Find more posts tagged with

jira