Did someone received from atlassian the validation documents for validation their products .
1. Jira version 8.x
The reason for this request is because
Non-Product Software Validation is a requirement of the Quality System Regulation, 21 CFR Part 820, 21CFR Part 11, and ISO/IEC 62304. Validation requirements apply to software used in medical devices, software that is itself a medical device, software used in testing and production of the medical device, and software used in implementation or support of the quality management system.
I will appreciate a respo0nse
Software Quality assurance Engineer
FLEX DESIGN, ISRAEL
Not sure if you found what you were looking for but keep in mind that FDA is very flexible with the software validation approach for non-product software. The level of rigor and documentation expectation can vary widely based on intended use of the tool. As you also probably know, this is also true of ISO 13485:2016. If a vendor supplies you with test documentation, it likely can form a foundation for the software validation plan and approach depending on its quality.
IEC 62304 is not applicable to non-product software though.
There are methods that one could possibly use for a cloud based tool that may be updated frequently. The key is intended use of the tool and impact of the update on previous software validation activities and documentation.
It’s been great to hear from fellow users over the last few weeks about the best tips and fun moments you’ve had working on Confluence since the transition to working remote. I’d love to keep the c...
Connect with like-minded Atlassian users at free events near you!Find an event
Connect with like-minded Atlassian users at free events near you!
Unfortunately there are no Community Events near you at the moment.Host an event
You're one step closer to meeting fellow Atlassian users at your local event. Learn more about Community Events