// 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.
The House of AI Trust™
A five-layer model for trustworthy AI in regulated drug development workflows.
The guide sets out the full architecture — and the control layer that converts governance from a set of principles into evidence an inspector can actually examine.
25-point readiness checklist
An organizational self-assessment across all five layers, scored so you can see which floor is missing before you build on top of it.
Regulatory timeline
What FDA, EMA, and the GAMP 5 / GAMP AI Guide lineage have asked sponsors to demonstrate, and when each expectation lands.
The control layer, in full
Layer 3 in operational detail, including the Probabilistic Validation Lifecycle — the seven-step model for systems where reproducibility is bounded.
No cost
Five layers. Two threads. One defensible system.
Each layer rests on the one beneath it. Two threads run vertically through all of them. Hover a layer — or a thread — to see what it covers and where to read more.