Life Sciences Series · Edition 01
The Frontier Model Dilemma: Why Governance, Not Model Choice, Determines Regulatory Defensibility
Frontier and open-weight models both break the assumption forty years of Computer System Validation rests on. Edition 01 of the Life Sciences Series names the AI Validation Gap, shows why model choice is not the deciding factor, and sets out Continuous AI Validation under GAMP 5 with ISO 42001, the NIST AI RMF and the EU AI Act integrated beneath it.