Protocol execution workspace
Detector response linearity
Failed
OQ-HPLC-02-001 · Revision 1 · HPLC-02 · OQ
TST-HPLC-02-DET-LIN-001 · TDEF-HPLC-02-DET-LIN-R01
Approved test design
- Objective
- Demonstrate detector response across the approved operating range.
- Instruction
- Execute the approved seeded detector-linearity test sequence.
- Expected result
- Detector response meets the approved numeric minimum.
- Approved acceptance criterion
- R² ≥ 0.999 across the approved detector response range
- Required evidence
- result export
- Prerequisites
- PRE-HPLC-CALIBRATION: MetPRE-HPLC-SERVICE-RELEASE: Met
EXEC-HPLC-02-DET-LIN-A01 · Attempt A01
Original execution — preserved
Failed result locked
This completed execution cannot be silently edited or converted to Passed. Any correction is a linked correction event; any retest is a new attempt.
- Observed result
- 0.994
- Criterion evaluation
- R² 0.994 does not meet the approved minimum 0.999. Quantitative response across the full intended range is not demonstrated.
- Completed
- 14 Jul 2026
EVD-HPLC-02-DET-LIN-A01HPLC-02 detector-linearity result export · seed://hplc-02/detector-linearity/run-001Pending
EXEC-HPLC-02-DET-LIN-A02 · Attempt A02
Controlled retest relationship
A01Original attemptFailed · retained
A02Authorized retestNot Ready · not interpreted
A future passing retest will not delete A01 or automatically remove the restriction. A separate report interpretation and validated-state decision remain required.
Next governed action
Conditional qualification is active and one controlled retest is planned. The original failed execution remains visible.
Acting as Validation Manager (Mara König). Actions remain visible when unavailable so the required role and state are explainable.