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Lois Goodsell, Manager Document Control

Lois Goodsell

Hi! I am new to this group and I work for a Medical Device company. I am looking to enhance JIRA & CONFLUENCE so that they are FDA Compliant.

I believe that I read somewhere there is an add-on that will make this possible, but I don't remember what it is and how to get it.

Any assistance with this will be appreciated.

Thank you,

Lois

Comments

marc -Collabello--Phase Locked-

Hi @Lois Goodsell ,

Welcome to the Atlassian Community.

Indeed, you probably need an addon to make your processes FDA compliant.

We make Document Control for Confluence Cloud , an addon which allows you to manage reviewers and signatures for document control. Our addon is free try for 30 days. Maybe it fits your use case.

Feel free to ask support@phaselockedsoftware.com if you have specific questions. We like to help.

Kristian Klima_gtcuat

@Lois Goodsell chances are it was me who mentioned that

Comala Document Management is used in FDA scenarios

You may also try Comala Document Control and Appfox's Workflows for Confluence to see if these can be configured to match the requirements.

Kristian Klima_gtcuat

Hello @marc -Collabello--Phase Locked-

Curious about your app - can it be configured so that it changes the Confluence page status (the native status) to, say Verified?

In other words, moving a page to the last stage of my workflow in your app would also apply a specific Confluence status.

I need a proper workflow but, at the end, I need the page to automatically 'fall' into a Confluence status so that it triggers another app for space synchronization (Space Sync for Confluence).

Thanks

Matteo Gubellini [SoftComply]

Hello @Lois Goodsell ,

We have an App (on Confluence Cloud) for Document Management designed around 21 CFR 11.

SoftComply Document Manager

You can try it for free, full features for 30 days.

We also have other Apps for the MedTech industry, see link below:

https://marketplace.atlassian.com/search?query=softcomply

Feel free to give us a shout if interested.

Matteo

Kristian Klima_gtcuat

That's quite a portfolio, thanks for sharing.

marc -Collabello--Phase Locked-

Hi @Kristian Klima ,

Thank you for the question.

At this moment we don't support setting/changing the document status, however this is on our roadmap and will be added soon. We do support webhooks and Confluence Automation, so you can build some workflows yourself. Feel free to contact us for support at support@phaselockedsoftware.com .

Stephen.Lugton

Hi @Lois Goodsell welcome to the group, it's good to see you've already got some suggestions to help you out

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