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ValidationV0
5

V0 seeded-state boundary: local demonstration data only. No live Sentinel, Augustus, Prism, Foundry or Depot synchronization; no electronic-signature, Part 11 or Annex 11 claim.

Active demonstration rules

idnamerulestatus
CLS-001GxP criticalityClassify by intended use, affected decisions and product or patient consequence.Active V0 rule
CLS-002Critical acceptance failureBlock progression until a controlled variance and proportionate risk assessment exist.Active V0 rule
CLS-003Sentinel escalationRequire escalation for hard patient, product, data-integrity or previously generated result impact triggers.Active V0 rule
CLS-004Temporary-control expiryRemove reliance at expiry and require a new approved decision for any extension.Active V0 rule