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21 CFR Part 11 compliant ALM / Test Management in Jira?

Dear all.

My company is looking for Jira based system for Application Lifecycle Management / Test Management which complies with US FDA 21 CFR Part 11.


 "US FDA 21 CFR Part 11 compliant" among other things mean that we a.o. are looking for the following regulatory required functionality:


  • Authoring of the following "document types" in the system: Validation Plans, User Requirement Specifications, Functional Specifications, FMEA risk assessment, Test Plans, Test Cases, Test Reports and Traceability Matrix.
  • Approve, lock and version control the documents via workflows.
  •   View audit trail of changes to the above.  


Is there anyone who knows if such a system or add-on exists for Jira?


Kind regards


4 answers

Hi @Bertrand Bourgeat ,


Document authoring. You could do this in various ways in Jira, Confluence, or connected systems and add-ons. People commonly create their own custom code to generate these documents and configure a whole set of add-ons for this.

Approve, lock, and version control the documents via workflows. This is a bit more challenging, there are solutions/addons to help with this, but many are snapshot-based, and are manually driven, leading to compliance risk.


Audit trails. This is a bit complicated, and while many solutions offer part 11 compliant audit trails many compliant and quality professionals debate this aspect of Jira. At the end of the day, with the right tools you could make this work for you, but it could take a considerable amount of effort to configure this properly.


These limitations led me to start a company that helps automate the Application Lifecycle Management with Jira, and other connected tools in a robust way, in just a few minutes! We just launched Ketryx on the Atlassian marketplace so you are welcome to take a look and try it out! 

Hi @Bertrand Bourgeat ,

For FMEA risk management, you can try out the SoftComply Risk Manager. 

In case you use FMEA with Detectability and the RPN calculations, feel free to try out the SoftComply Risk Manager Plus

In case you would like to learn more about these apps, we'd be happy to demo them to you

You can also check out some video tutorials on establishing traceability in Jira and Confluence.

Hope this helps!

Kind regards, Marion

Thank you Marion.


I think the reply to Matteo also applies here.


Kind regards


3 votes
Matteo Gubellini _SoftComply_
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May 27, 2021 • edited

Hello @Bertrand Bourgeat

We have a solution 21 CFR 11 compliant for Confluence, I'm not sure if there is anything for Jira.

We also have add-ons for risk management on Jira, including FMEAs.

Feel free to reach us at





HI Matteo.


Many thanks for your reply. We are however looking for full ALM solution, from planning, requirements management, risk management to test management.


Kind regards


0 votes
Radoslaw Cichocki _Deviniti_
Marketplace Partner
Marketplace Partners provide apps and integrations available on the Atlassian Marketplace that extend the power of Atlassian products.
May 27, 2021 • edited

Hi @Bertrand Bourgeat ,

TestFLO - Test Management for Jira + Electronic Signature for Jira can meet most of your requirements, plus some additional apps and some additional configuration that your Jira administrator can perform. Or an Atlassian partner like Deviniti.

Have a listen of a part of my presentation from Jira Day where I described how to implement test case approval when the approval requires a signature to be CFR 21 part 11 compliant.

Important note: TestFLO is available for Jira Server and Data Center hostings only. Electronic Signature will be available for Data Center most likely within 3 months, currently it's only there for Jira Server.

Radek Cichocki
Product Owner of TestFLO

Hi Radoslaw.

That looks relevant. I will reach out to Divinity to get more information.

Thank you,


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