Hi all, and my first post here. We are having an internal debate and the question comes up "Is formal validation required for tools used in a...
Hi, Wondering if anyone has any advice (or can direct me to some formal guidance) with respect to how to adequately validate mobile medical...
Curious: The just-released ISO 13485:2016 will require vigilance regarding validation of QMS software. I'm wondering to what degree this would...
21 CFR §820.70(i) (i) Automated processes. When computers or automated data processing systems are used as part of production or the quality...
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