Jira Test Management Add on for Pharma software validation

[Rexon M]

Dear All,

I am working for pharma and healthcare related software company. For the software validation part, we would like to use Atlassian products like Jira or Jira add on for test execution. I would really appreciate if you could share your experience using Jira test management add on for pharma software validation. If yes, which ones are perfect fit with respect to pharma compliance since ideally we need to have the test management tool validated before using it for validating a pharma software. Thank you in advance.

Kind regards,

Rex  

[Michael Iglesias]

Hello Rexon,

I have worked at two major pharma companies using Atlassian to support design controls for software products. At both companies, we found Xray met our needs the best.

Michael

[Rexon M]

Thanks a lot Michael. Does it provide an option to review and formally approve test scripts through a workflow? And also help creating a traceability matrix at the end?

[Michael Iglesias]

Xray will allow you to assign a workflow for the test issue types that it includes. My dev. teams either assign the test issues to me manually, or push it through the workflow and have it automatically assigned to me. I can then go in, review, and send backwards or approve via the workflow.

For creating a traceability matrix, you may be able to get the native export functionality to work to your liking; however, you may find Xporter offers additional functionality for exporting.

[Matt Therrien]

@Michael Iglesias , Do you use Xray for both manual and automated tests?  What was your experience with the test automation with regards to ramp up?  It looks like by using Gerkins it seems like a pretty low bar to entry.  Also did you find it difficult to associate or redesign how you structure and use of items in Jira to align with the various regulatory needs <Stories, requirements, design specs>?

[Michael Iglesias]

Hi Matt,

My product teams use Xray for both manual and automated testing. I don't have specific details to share experience with the automated part as that is outside the scope of my role. You can reach out directly to Xray on this subject.

As for structuring Jira issues, I have worked with teams that wanted to use the out-of-the-box default issue types and I've had them define this in the Software Dev. Plan requirements and agile sections.

I would highly recommend that you consider Jira issues such as user stories, epics, etc. as design inputs, if they trace to requirements.

Other teams I have worked with, wanted a direct 1:1 labeling of Jira issues with the SOP's requirements (e.g., product requirement, system requirement, software requirement, bug, defect, anomaly).

[Matt Therrien]

Thanks, this is helpful.

[Nina Zaradniak_Deviniti_]

Hi Rexon,

What type of hosting for Jira are you going to choose, will it be a Data Center or Cloud? If it's DC, then I recommend TestFLO. This tool allows for a very extended configuration and will help to fit your process. It will support you in the approval process by using appropriate statuses on the workflow and various conditions and post-functions. You can also easily check traceability.

Cheers,
Nina.

[Rexon M]

Many thanks Nina for your great advice. I will check that. We are also focusing or trying to get ideas how and what other pharma companies are generally using to manage their validation.

[Nina Zaradniak_Deviniti_]

Fair enough, if you would like to learn more about TestFLO I encourage you to contact us through our Customer support portal where we will provide you with more details.

Cheers, Nina.

[Matt Therrien]

Hi Rexon, 

I was curious to hear about where you landing with regards to this topic.  I'm looking at some various options as well and I'd be happy to hear your experience.