Skip to main content
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.

Controlled execution response

Controlled Variances

Departures, exceptions, failures, temporary controls, amendments and retests remain distinct and linked to the approved plan and actual evidence.

Open variances
1
Critical / high
1
Active controls
1
Sentinel required
1

Variance register

VarianceTypeSeverityProtocol / TestRiskValidated-state impactTemporary controlSentinelStatus
Acceptance-Criteria FailureCriticalOQ-HPLC-02-001
TST-HPLC-02-DET-LIN-001		AcceptedYesActiveRequiredAwaiting Retest

Critical

VAR-HPLC-02-001 · Acceptance-Criteria Failure

Approved approach
Detector response shall meet R² ≥ 0.999 across the approved range.
Actual result
Seeded observed result R² 0.994 did not meet the approved criterion.
Immediate action
Prohibit quantitative assay use and assess restricted qualitative identity use.
Retest required
Yes — controlled authorization only
Report disclosure
Required
Disposition
Conditional restricted use approved; retest remains required.

Accepted

RA-HPLC-02-001 · Risk assessment

Hazard / failure mode
Detector response is not demonstrated across the approved quantitative range.
Potential consequence
Quantitative results may not be scientifically supported.
Initial risk
High
Residual risk
Medium
Acceptance authority
QA Reviewer
Rationale
Qualitative identity use does not rely on demonstrated quantitative response across the full range.

Formal quality-system boundary

Sentinel escalation required

Sentinel escalation is required: formal investigation required, critical failure prior result impact.

  • FORMAL_INVESTIGATION_REQUIRED
  • CRITICAL_FAILURE_PRIOR_RESULT_IMPACT

Boundary state: External Action Required. Linked change CHG-2026-031 is a seeded reference; no live synchronization or Sentinel workflow is implied.

Acknowledged · external action open

Current use restriction

TC-HPLC-02-001 · HPLC-02 qualitative identity use only

Active

Qualitative identity testing only.

Permitted
Qualitative identity testing
Prohibited
Quantitative assay
Owner
Mara König
Expiry
15 Aug 2026
Review frequency
Every 7 days
Monitoring
Verify intended-use selection before each use and review weekly.
Permanent resolution
Investigate detector response, complete approved retest and update the qualification report.
Termination criteria
Terminate on failed monitoring, expiry, or approval of a superseding qualification decision.

Approved

Retest control

Authorization
RET-HPLC-02-001
Original execution
EXEC-HPLC-02-DET-LIN-A01
Scope
Repeat the approved detector-linearity test once after prerequisites are documented.
Investigation reference
Seeded external investigation action; Sentinel workflow is not implemented.
New attempt
EXEC-HPLC-02-DET-LIN-A02

None proposed

Protocol amendment

Technical amendments create a prospective test-definition revision. They never rewrite completed execution history.