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Rally Software review
Manager Global Tools at a healthcare company with 1,001-5,000 employees
You can view the hierarchy of issues. It is not compliant with FDA regulations on...
It is not compliant with the FDA regulations on electronic signatures (21 CFR part 11), which is required for regulated industries. We produce medical devices, which means we have to comply with the FDA regulations if we wish to sell in the U.S. One of these relates to being able to have electronic signatures within the tool, when we close...
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