FDA quality system in Confluence

[Arianna Sunbear]

Hi all -

I am interested in using Confluence for my organization -- I would like to find out if anyone has set up an FDA-style quality system in Confluence. Of special interest is: how would one handle managment approvals within such a system?

Any and all comment is welcome and appreciated!

[Gorka Puente _Appfire_ · Accepted solution]

Hi @Arianna Sunbear,

We released a document that describes how some of our customers (Comalatech) achieve compliance with the FDA Title 21 CFR Part 11 regulatory requirements for Electronic Records and Electronic Signatures using Comala Workflows.

You can find it here. Check it out and let us know what do you think. If you are also interested in ISO 9001, please contact us through our support system.

Kind regards,

Gorka

[Matteo Gubellini _SoftComply_]

Hi Arianna,

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

Regards

Matteo

[Ellen Feaheny [AppFusions]]

Cross-linking the question with this:

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

[Ellen Feaheny [AppFusions]]

Hello Ari

Happy to discuss this with you -

On a sep note, we have a plugin to also help meet your FDA compliance needs in JIRA. Maybe you want to check that out in meantime.

Best,

Ellen
ellen@appfusions.com