2BP ← library
Instance · Live · 08 May 2026
01

Validation Is Not Trust: Why Pharma AI Needs a Safety Case

THE GUEST BODY  Petri Pohjanen THE STANCE  the governance-rigour one
AI governanceGxPvalidationsafety case
THE FOUR CONSTANTS
The guest body
Petri Pohjanen — held release authority on ISO 26262 ASIL-B programmes before pharma AI; a mind for safety-critical systems where reproducibility was never the real question.
The stance it summoned
The governance-rigour one — the regulated-industry stance that lives where a wrong call reaches a patient.
The unknown on the table
If a language model can't be reproduced bit-for-bit, what does "validated" even mean — and is determinism the wrong thing to be chasing?
The residue
The safety case — borrowed from automotive functional safety: a defensible argument that a system is grounded in approved sources, that anyone can build for their own system.
THE DISCUSSION · WHERE THE ALIVENESS LIVES
Video or podcast · coming
THE RETICLE · THE RESIDUE YOU READ IT THROUGH
Cover illustration — Validation Is Not Trust
THE ARTEFACT
"Validation Is Not Trust: Why Pharma AI Needs a Safety Case"
Article · LinkedIn · 08 May 2026 · Nuno Valério & Petri Pohjanen
What it leaves a stranger: a safety-case scaffold — stop demonstrating bit-exact reproducibility, start arguing that outputs are grounded in approved sources. A structure you can lift into your own validation file.
Read the article →
Join the discussion on LinkedIn →
REFERENCES · THE GROUND IT STANDS ON
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