FDA Part 11 and AI-Generated Code
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2 Articles
For several months, large Open Source projects have positioned themselves for or against the pull requests, the code submissions generated by the AI. Sometimes rather favorable, regularly against or strongly framed. The CCG Steering Committee announces that it has accepted the recommendations of the CCG AI Policy Working Group. De facto, CCG will not accept any legally significant contribution (with a significant legal impact) generated by an ag…
FDA Part 11 and AI-Generated Code
AI-generated code doesn't automatically meet FDA electronic records requirements. This article examines where AI-generated internal applications fail 21 CFR Part 11, why the risk compounds across pharma and medical device IT organizations, and what a governed approach to internal app development looks like before the next inspection. The post FDA 21 CFR Part 11 and AI-Generated Code: What Pharma and Medical Device IT Teams Must Validate appeared…
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