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FDA quality system in Confluence

Arianna Sunbear1

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!

Accepted answers

Gorka Puente {Appfire}

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

All comments

Ellen Feaheny [

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

Ellen Feaheny [

Cross-linking the question with this:

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

Gorka Puente {Appfire}

Hi @Arianna Sunbear,

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

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