Batch BT-020184
Bioxalin • NWK • L035 • released
About this view
This batch detail page ties execution evidence, material genealogy, equipment fitness, in-process controls, and quality events into one release-focused view. Users can trace each unit operation against timestamps and investigate linked exceptions without leaving context. The panelized layout supports QA review by exception while preserving full evidence access. Next actions include closing residual issues and completing disposition-ready evidence checks.
Planned
2026-05-08 → 2026-05-13
Actual
2025-05-27 → 2025-09-09
Exceptions
7
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010920 | Water for Injection | approved | Open workbench |
| LOT-010921 | Purified Water | quarantine | Open workbench |
| LOT-010922 | Ethanol 95% | hold | Open workbench |
| LOT-010923 | Isopropyl Alcohol | rejected | Open workbench |
| LOT-010924 | Methylene Chloride | expired | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01304 Compressed Air System #305 | in-calibration | 2026-05-29 | not-qualified |
| AST-01305 HVAC Unit #306 | in-maintenance | 2024-11-22 | qualified |
| AST-01306 Refrigerator #307 | out-of-service | 2024-10-09 | qualified |
| AST-01307 Freezer Ultra-Low #308 | cleaning-required | 2024-10-27 | qualified |
| AST-01308 Incubator #309 | operational | 2026-02-28 | requalification-due |
| AST-01309 Autoclave Sterilizer #310 | operational | 2024-09-10 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
QA Review Checklist and Signatures
- Step execution completeness verified with signed evidence.
- All high-severity exceptions dispositioned or justified.
- QC release tests reviewed and OOS investigations closed or dispositioned.
- Final release signatory validated with segregation-of-duties check.
Release Readiness: BT-020184
Score: 93
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.