The best time to raise validation questions about an AI tool is before a pilot starts, not after it has already influenced a real decision. A short list of questions upfront avoids the harder conversation of unwinding a pilot that quietly became load bearing.
What decision will this tool's output actually influence, and could that decision ever touch a GxP relevant outcome, even indirectly. Teams often underestimate how quickly a tool piloted for convenience becomes something people actually rely on for a real decision.
Can the tool show why it produced a given output, in a way a reviewer could actually verify, or does it just present a confident answer with no visible reasoning. A tool that cannot support its own output is harder to trust even when it happens to be right.
What happens when the tool is uncertain, does it say so, or does it produce a confident sounding answer regardless. And critically, who gets notified if the pilot's scope starts expanding beyond what was originally approved, so it does not quietly become production use without anyone formally deciding that.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
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