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Assessments
Every record, graded and routed.
The AI proposes the risk factors; fixed rules (ICH Q9) compute the grade and decide who looks at it.
Showing the Manufacturing stage only. Show all stages
| Assessment | Source | Stage | Grade | AI confidence | Status |
|---|---|---|---|---|---|
| Grade B cleanroom: two non-viable particle excursions ASM-0014 | LIMS ENV-26-0933 | Manufacturing | D4 | 83% | Needs review |
| Like-for-like HVAC filter replacement ASM-0013 | EQMS CHG-2026-077 | Manufacturing | A1 | 98% | Cleared by AI |
| Aseptic gowning requalification current for all staff ASM-0011 | LMS TRN-0322 | Manufacturing | A1 | 94% | Cleared by AI |
| Autoclave IQ executed with one calibration deviation ASM-0010 | EDMS VAL-IQ-0045 | Manufacturing | C3 | 79% | Needs review |
| Batch record missing a second-person verification ASM-0009 | MES MES-MFG-0288 | Manufacturing | C3 | 86% | Needs review |
| Batch 24-0871 assay results within specification ASM-0003 | LIMS BATCH-24-0871-ASSAY | Manufacturing | A1 | 95% | Cleared by AI |