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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.

AssessmentSourceStageGradeAI confidenceStatus
Grade B cleanroom: two non-viable particle excursions
ASM-0014
LIMS
ENV-26-0933
ManufacturingD483%Needs review
Like-for-like HVAC filter replacement
ASM-0013
EQMS
CHG-2026-077
ManufacturingA198%Cleared by AI
Cold-chain shipping lane not yet qualified for summer
ASM-0012
ERP
SO-55120
DistributionB270%Needs review
Aseptic gowning requalification current for all staff
ASM-0011
LMS
TRN-0322
ManufacturingA194%Cleared by AI
Autoclave IQ executed with one calibration deviation
ASM-0010
EDMS
VAL-IQ-0045
ManufacturingC379%Needs review
Batch record missing a second-person verification
ASM-0009
MES
MES-MFG-0288
ManufacturingC386%Needs review
Stability study 23-114, 12-month timepoint within limits
ASM-0008
LIMS
STAB-23-114-12M
Research & DevelopmentB293%Cleared by AI
CAPA-2026-031 effectiveness check closed
ASM-0007
EQMS
CAPA-2026-031
Quality SystemB290%Cleared by AI
New excipient supplier introduced without qualification on file
ASM-0006
ERP
PO-88213
Quality SystemD462%Waiting on team
Packaging line 2 label reconciliation variance
ASM-0005
MES
MES-PKG-0553
PackagingD481%Needs review
GMP training current for packaging line 2 operators
ASM-0004
LMS
TRN-0310
PackagingB292%Cleared by AI
Batch 24-0871 assay results within specification
ASM-0003
LIMS
BATCH-24-0871-ASSAY
ManufacturingA195%Cleared by AI
SOP-MFG-014 rev 7 periodic review completed on time
ASM-0002
EDMS
SOP-MFG-014-R7
Quality SystemA197%Cleared by AI
Temperature excursion in cold storage room 3
ASM-0001
EQMS
DEV-2026-0142
DistributionC388%Needs review