dhf design history file

[arnold liao]

has anyone used confluence/JIRA in a regulated environment i.e. FDA/ISO

[Erez Kaminski -Ketryx-]

Hi, @arnold liao and @miglesias, yes! there are many teams using Jira for FDA related product and system development. We have recently released Ketryx to the Atlassian marketplace (link) to solve this exact issue, how to automatically configure Jira and other common dev tools to create a traceable, self-documenting, and compliant SDLC.

You can try it yourself, or schedule a time with us to talk!

Develop fast, stay compliant! 

[Matteo Gubellini _SoftComply_]

Hi Arnold,

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

[miglesias]

Hello Arnold, did you get the answer to your question? I have the same challenge and haven't found the best option.