My company is looking into a tool that will help us satisfy the rigorous requirements of ASPICE. My question is pretty simple: Is Atlassian even a choice for satisfying ASPICE requirements? Does anyone have any experience trying to implement it for ASPICE?
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Hi Josh,
It might be worth checking out Structure and Structure.Pages (for Confluence integration) for traceability requirements.
Check out the following videos:
https://www.youtube.com/watch?v=9_Qr8Utl0jE (quick 30s intro to Structure.Pages)
https://www.youtube.com/watch?v=15HpABPX9fc (40 min webinar on Structure + Structure.Pages)
https://www.youtube.com/watch?v=lpng2A8UTfw (how biotech, medtech and pharma use Jira + Structure to track their requirements)
Hello Jimmy,
Are you aware of an add-on like this that works with JIRA/Confluence Cloud?
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Hi Sven,
Reach out to the team at ALM works and they can give you more information. I believe Structure Cloud exists (potentially in private beta), but pages and Gantt probably do not yet. They're looking to understand the market so reach out and let them know
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Indeed, Structure Cloud 1.0 will be launched very, very soon, @Josh Goulet (One might suspect that could possibly happen at some appropriate industry event, in a place like Las Vegas, in 10 or so days, for example.)
In your case Structure.Pages would be nice-to-have IMO, for sure, but nearly all of the things that @Rina Nir shows in the "how biotech, pharma, etc." video above can be done with links between Jira issues and Confluence pages (+ Structure) as a perfectly suitable way of doing things.
Rina also writes about this topic here: https://almworks.com/blog/2018-04-structure-in-life-sciences.html
Hope this helps,
-dave [ALM Works]
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You'll probably need to explain what "ASPICE" is for most of us. (The short answer is "yes, if configured suitably" though)
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ASPICE is a process that provides evidence that you have correctly planned and implemented all the requirements of the project from start to finish. It requires very strict tracing to prove that you have everything covered.
My main issue currently with the trial is that I can't trace a requirement from a Confluence page directly to a JIRA task. It only refers to the document as a whole. Also, if a Confluence page paragraph or sentence changes, how to any upriver or downriver traces get notified of the update?
I was not able to find any add-ons specifically tailored to this traceability issue.
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