JIRA CLOUD vs FDA

[Manoel Ramon]

I understand when we have JIRA installed in a local server, we can control the software versions and patches. Thus, we can run a validation and be approved by FDA.

What about Cloud Jira ? we do not control what is being updated and on this case how to validate JIRA and be accepted by FDA ?

Thoughts ?

[Josh Steckler]

Hi Manoel,

In my experience, you can make a SaaS application part of your FDA regulated suite of applications, but you will require certain documentation such as contingency plans, local backup, and acceptance from a company compliance officer.

It's my recommendation to consult with a company that specializes in FDA medical/pharmaceutical regulation in order to determine what is required and if cloud is feasible.