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PainChekQA's avatar
Occasional Visitor
3 years ago

Validation Reports of Zephyr Squad Test management tool for use FDA and CE submission

Did anyone receive validation documents for Zephyr Squad product validation from SmartBear?

I am asking this question as 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. Accordingly, product validation reports from vendor can be used as supporting documents in Computer System Validation.


Appreciate your help.


Best Regards


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