Notes · Governance.
The feed of writing relevant to governance practice. EU AI Act, QMSR, ISO/IEC 42001, GMP Annex 22, ICH Q9(R1), validation of non-deterministic systems, the immunity-model framing. Filtered from the global archive.
View global notes archive →Vaccine and antidote: the missing vocabulary for AI in regulated life sciences.
The framework regulated industries already have for absorbing agents that bring possibility and vulnerability — translated into AI deployment.
EU AI Act high-risk classification: worked example for a pharma AI inventory.
How to walk through Annex III against a real pharma company's AI footprint. What gets flagged, what doesn't, what the conformity assessment actually involves.
PCCP architectures for adaptive AI in medical devices.
What a Predetermined Change Control Plan should actually contain for an AI/ML system that is going to update. Reading the FDA guidance against current submissions.
GMP Annex 22 readiness: what the public consultation tells us.
Reading the draft Annex 22 alongside the EMA AI Reflection Paper. What pharma manufacturing should be doing now, before final publication in H2 2026.
Validation of non-deterministic systems: passing FDA inspection.
How IQ/OQ/PQ adapts when the system doesn't return identical output to identical input. Reference test sets, statistical envelopes, drift detection in practice.
The 2025 483 pattern for bioanalytical: ISR, reagent-lot, partial validation.
FDA's top inspection findings in bioanalytical operations 2025. Why ISR sample-selection randomisation hit 28% and what to do about it before the next inspection cycle.
ISO/IEC 42001 in pharma: what the AI management system standard actually requires.
The first international standard for AI governance. Reading 42001 against existing pharma QMS — where they overlap, where 42001 fills genuine gaps, and where the standard is too generic for regulated life sciences.
QMSR effective Feb 2026: the combination-product bridge that wasn't documented.
21 CFR 820 harmonised with ISO 13485. The DHF-to-BMV handshake that nobody pre-staged. Why it's becoming a top-5 483 category by 2027.
Governance as an immune system: why structure beats policy.
The architectural argument for treating quality governance as an active immune system rather than a static rule set. Why structure beats policy at the operational layer.