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

This widget could not be displayed.

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

This widget could not be displayed.

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

This widget could not be displayed.
Jason Worley 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

Suggest an answer

Log in or Sign up to answer
Atlassian Summit 2018

Meet the community IRL

Atlassian Summit is an excellent opportunity for in-person support, training, and networking.

Learn more
Community showcase
Published Jul 30, 2018 in Confluence

How Manon Soubies-Camy uses Confluence + Trello to organize webinar notes and her knitting stash

@Manon Soubies-Camy is an engineer who has been an avid Atlassian user since 2014. She helps companies of all sizes transform the way they work with the Atlassian stack, including Jira and Confl...

866 views 8 13
Read article

Atlassian User Groups

Connect with like-minded Atlassian users at free events near you!

Find a group

Connect with like-minded Atlassian users at free events near you!

Find my local user group

Unfortunately there are no AUG chapters near you at the moment.

Start an AUG

You're one step closer to meeting fellow Atlassian users at your local meet up. Learn more about AUGs

Groups near you