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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.

Programme

Periodic Reviews

Current, due and overdue reviews that maintain validated state.

Lifecycle review control

A review date does not itself extend or renew validated state.

Review forecast

ItemCurrent stateReview dateNext action
Conditionally Qualified23 Jul 2026Execute detector linearity OQ test
Qualified with Restriction18 Aug 2026Complete point-of-use 4 PQ
Revalidation Required18 Aug 2026Execute scheduled smoke study
Qualified18 Aug 2026Review return-loop TOC trend
In Validation18 Aug 2026Schedule three PPQ batches
Planned18 Aug 2026Define seal-integrity challenge
In Validation18 Aug 2026Execute dirty hold-time test at 72 hours
In Validation18 Aug 2026Complete technical review
Planned18 Aug 2026Complete URS and GxP risk assessment
Revalidation Required18 Aug 2026Complete formula revalidation
Temporary Controlled Use18 Aug 2026Resolve 18 reconciliation records
In Validation18 Aug 2026Collect 72-hour time point
Qualified with Restriction18 Aug 2026Plan winter seasonal qualification
Restricted18 Aug 2026Complete logger-excursion risk assessment
Planned18 Aug 2026Execute scheduled smoke study