Questions about Jira Compliance Part 11 FDA

[Elif Avsar]

Hello all,

my name is Elif and i`m a working IT-student a big pharma-company in Switzerland. We are very interested in using the software Jira for our requirements-management. But according to very strict pharmaceutical GMP guidelines and the law, the software we will use have to fulfill some requirements. For example the software has to enable electronic signature and fulfill the part 11 guidelines from the FDA. Does Jira have certain functionalities that must be fulfilled from a validation point of view? The functionalities are following:

--> It should be possible to define in the system that passwords periodically expire and need to be revised
--> Are electronic records possible? Records should be protected against intentional or accidental modification or deletion. And upon making a change to an electronic record, the previously recorded information shall still be available. So far an electronic record’s audit trail should be retrievable throughout the record’s retention period.
 --> Possibility of an electronic signature. The electronic signature should be made up of at least two components, such as an identification code and password.
--> An approval and review-process to approve / review workitems.
--> If an workitem is denied, an change-process should initiate including a change-request-review and -approval.
--> It should be possible to create test cases. It should be possible to review and approve the testcase and block it for editing before the test execution. It shall be possible to execute approved test cases and provide test outcome as actual result per test step. There should also be available test result categories.
--> A risk assessment should be carried out for each GxP critical requirement.

Thank you very much for your support!

[Yuliia_Borivets__SaaSJet_]

Hi @Elif Avsar 

In general, it's possible. I know some companies use Jira to comply with Part 11 FDA. But built-in functionality usually isn't enough. You will need to combine it with some plugins from the Marketplace. Jira offers an audit log for some system changes:

Auditing in Jira

Audit log events in Jira

For changes within the issues list made by users (including deleted ones) and export, you can try the Issue History plugin. It's developed by my team.

Additionally, you'll need the e-signature fields plugin.

Also, this article can be helpful:

Jira for CFR 21 Part 11 compliance: how to get audit trail for FDA inspection

[Elif Avsar]

Hi @Yuliia_Borivets__SaaSJet_ !

Thank you very very much for your input! I see, there are lot of things I`ve to check out before being able to use Jira for my purpose. Pharma and IT doesnt fit together every time ... Will not be easy, but interesting :) 

[Yuliia_Borivets__SaaSJet_]

Jira is known for its agile and customizable possibilities. But, yes, you should check if it fits your case.

I wish you find the best solution for your company.