Client:Aurora Pharma Ltd.·Validation Env·Tenant ID:aurora-prod-01
Validated System · 21 CFR Part 11 · GxP-aware
Site
Plant
Dept
Range

Operations Dashboard

Cross-functional health for Hyderabad Plant · Plant A — Solid Dose · Validation environment

Open deviations
47
+6 vs last week
CAPA overdue
12
3 critical
Yield variance
-2.4%
Target ±1.5%
Inventory shortage
9
2 critical materials
Predicted maint risks
6
Next 30 days
EHS incidents (mo)
3
–2 vs last month
PPE compliance
96.4%
Target ≥ 95%
AI pending review
18
Human-in-the-loop

Deviation trend

Opened vs closed by month

CAPA effectiveness

% of CAPAs effective on first review

Inventory expiry risk

Material at-risk lots by class (next 90 days)

Equipment failure risk

Predicted risk score by asset group

High-priority alerts

IDModuleTitleSeverityOwnerAge
ALT-2041ProductionYield variance exceeded on Batch BMR-22441HighR. Kapoor2h
ALT-2042QARepeat deviation pattern: Mixing time excursionHighS. Iyer5h
ALT-2043MaintenancePredicted bearing failure — Filling Line-03CriticalA. Khan1d
ALT-2044StoreAPI-001 below safety stock at NJ PlantMediumM. Rao1d
ALT-2045EHSPPE non-compliance spike — Block C, Shift BMediumD. Shah2d

Cross-functional pattern detected

Human review required

Yield deviations on Filling Line-03 correlate with bearing vibration anomalies and a recent excipient lot change. Suggest joint Production–Maintenance–QA review.

Confidence 84%

Action items by owner

IDOwnerTitleDueStatus
ACT-501R. KapoorInvestigate yield deviation BMR-224412025-04-22Open
ACT-502S. IyerApprove CAPA-118 effectiveness review2025-04-23Under Review
ACT-503A. KhanSchedule PM for Filling Line-032025-04-21Overdue
ACT-504M. RaoReorder API-001 — vendor Synthon2025-04-25Open

Recently reviewed AI recommendations

IDModuleRecommendationConfStatus
AI-9011QALikely root cause: Operator step skip in granulation phase87%Approved
AI-9012MaintenanceSchedule bearing replacement within 14 days92%Pending
AI-9013StoreReallocate Excipient-017 from Pune to NJ74%Rejected