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onDemand for FDA + ISO compliance

Is anyone using Jira onDemand with Confluence for the fully FDA and/or ISO compliant SDLC? Where would we begin with that?

We recently adopted Jira onDemand but now we have a project that requires FDA and ISO compliance. Some of the regulations I've been asked to have our software comply with are ISO 13485 and IEC 62304 Level 2.

I see that there are some modules for some bespoke requirements around FDA (that incidentally can't be installed in onDemand) so one might assume that someone is successfully using Jira (probably the self hosted version) in this environment.

3 answers

1 accepted

4 votes
Answer accepted

Hi @Paul Burden,

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

Like Gorka Puente _Appfire_ likes this

Hi Paul,

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

0 votes
AgentSmith Atlassian Team Feb 02, 2014

Best I can do is refer you to this previous posting - Tim is correct:

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

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