What addons are best for FDA compliance?

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

5 answers

1 accepted

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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

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SoftComply has created two add-ons specifically for medical device software companies - SoftComply Risk Manager is based on ISO 14971 and supports the traceability between risks and software requirements (and test cases for verification of mitigation actions).
SoftComply eQMS (currently without workflows) provides a set of technical documentation based on the requirements of ISO 13485 and 21 CFR 820. 
https://marketplace.atlassian.com/search?query=softcomply

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Hi Steve,

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 will contain answers to most of your doubts.

Regards

Matteo

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AppFusions has this plugin addressing this FDA compliance use case for JIRA ... we have a number of customers using this. It's been out for just over a year now.

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

Please also see related threads - search for FDA. Here's a couple:

https://answers.atlassian.com/questions/153167/compliance-market-requirements-standards-for-jira-fields-capture-market-requirement-by-segment

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

There are corps out there (e.g., pharma, medical, food supply, etc.) that are using JIRA/Confluence in this way now - I know.

My email is ellen@appfusions.com if you would like to discuss/vet more.

Best,

Ellen

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One particular issue with JIRA is that the audit history of what changes were made to each JIRA element are not robust enough.  For instance, I can see when the last change was made to a workflow and who made it, however, there is not any automatic storage of the change that was made.

Hello, that's correct. But: you can do a copy of the workflow right before you publish your changes. Name it with a version number and generate an JIRA entry corresponding to that verison number or copy and describe your changes - that's it, I think. 

 

Regards, Matthias

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