// insights
The AI Validation Boundary: Extended Edition
Methods, frameworks, and field notes for validating probabilistic AI systems in regulated drug development, sent when they publish.
Coherence ≠ Compliance: The Capability Paradox, 10 Months Later
In December, The Capability Paradox argued that more capable LLMs raise the validation burden instead of lowering it. Ten months later, the diagnosis holds, but the fix was aimed at the wrong place. When a model’s mistakes read as fluent and correct, the reviewer becomes the control, and someone has to qualify the reviewer.
The Inheritance Boundary Inside the House
What AI validation evidence can GxP teams inherit from suppliers and QMS, and what must they own? A floor-by-floor walk up the House of AI Trust.
The Validation Boundary Inside the House
In GxP, the validation boundary for AI isn't the model alone. It's context of use, model, harness, and human-in-the-loop, across every layer of governance.