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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.

Validation project workspace

HPLC-02 Qualification After Major Service

Execution In Progress

EQ-HPLC-02 · Equipment Qualification · OQ

Owner: Mara KönigTechnical lead: Elias NcubeQA: Nadia MoyoPlanned completion: 31 Aug 2026

Current use restriction

Conditionally Qualified

1 temporary control

The failed detector-linearity execution remains visible and unresolved. This restriction defines what remains scientifically supported.

Permitted
Qualitative identity testing
Prohibited
Quantitative assay

Purpose and strategy

Validation item
Project type
Equipment Qualification
Validation strategy
Risk-based lifecycle execution using approved requirements, evidence and controlled departures.
Linked change control
SENT-CHG-2026-031 Seeded reference
Next decision
Assess detector linearity failure

Completion conditions

  • Investigate detector response
  • Execute the single authorized retest
  • Update qualification report
  • Reassess Prism quantitative method capability