Hi I am Phil

[Hallmark Surgical QMS]

I am currently working on a project to implement Quality Management System to medical device company to gain accreditation for ISO 13485, wondering if there is a simple process to set up CAPA processing and recording.

[John Funk]

Welcome, Phil!

[Hallmark Surgical QMS]

Thanks John

[Matteo Gubellini _SoftComply_]

Hi @Hallmark Surgical QMS

The simplest by far would be to create a process in Jira. You can set up a workflow that matches your process, set up the issue fields per your requirements and add conditions and transitions as necessary.

Otherwise you can do it in Confluence, but you will need Apps to add workflows to it.

In both cases you will need anyway an App for electronic signatures.

Feel free to check our App for Confluence SC Document Manager 

Matteo

[marc -Collabello--Phase Locked-]

Welcome @Hallmark Surgical QMS ,

How you set up your CAPA process depends on your overall Quality Management System.  If you set up your QMS documents in Confluence, you can use our addon so sign and approve these documents: Document Control for Confluence Cloud

The simplest process for CAPA is probably to directly follow the FDA guidance and record every step.  This works as long as you don't have too many CAPA actions running.

[Hallmark Surgical QMS]

Thanks marc-  We are setting up all QMS documents in Confluence and am currently  working thru the process of configuring Jira to record info submitted regarding CAPA issues, Am wanting a configuration that can automatically open a CAPA Template to be filled out online when we activate create and when it is submitted it will automatically send notification to Regulatory Affairs Department as well as moving it on the board to Investigate stage and open the 2nd part of the form to Investigate and attach detail workings on Action Plan this will then need to follow thru to Monitor stage before closing and Archiving, Trying to work with Smart Jira Forms seem great to create a nice Template but just struggling with the automation process etc.