Are any of the modules of JIRA compliant with 21CFR 11 (FDA electronic records/electronic signature requriements). If so, which ones?
Do you have any customers that make software medical devices that are using JIRA (or add-ons)? If so, which components?
AppFusions has this plugin addressing this FDA compliance use case for JIRA ... we have a number of customers using this. It's been out for just over a year now.
Please also see related threads - search for FDA. Here's a couple:
There are corps out there (e.g., pharma, medical, food supply, etc.) that are using JIRA/Confluence in this way now - I know.
My email is firstname.lastname@example.org if you would like to discuss/vet more.
To answer “How scrum works,” most of the teams I've worked with first addressed the question: “where to start?” That question applies to both implementation and improvements on the Scrum framew...
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