QualityGuard

Quality: Intelligent Deviation & CAPA Management

Here's what's happening at Site A - Boston today.

Open Deviations

3 -12%

Critical Issues

1 Stable

Active CAPAs

2 +2

AI Recommendations

1 3 high

Recent Deviations

IDTitleSeverityStatusDate
DEV-2023-001Temperature Excursion in Bioreactor 4MajorInvestigating10/25/2023
DEV-2023-002pH Drift in Buffer PreparationMinorOpen10/26/2023
DEV-2023-003Particulate Matter in Vial InspectionCriticalInvestigating10/24/2023
DEV-2023-004Pressure Drop in Filtration UnitCriticalClosed10/10/2023
DEV-2023-005Labeling Error on Packaging Line 2MajorClosed9/15/2023

AIPreventive Insights

Predictive Maintenance for Cooling Valves

92% Risk

Analysis shows 85% correlation between valve age > 2 years and sticking issues. Recommend proactive replacement cycle.

Based on 3 similar deviations

Standardize Buffer Prep Mixing Speeds

65% Risk

pH drift correlates with variable mixing speeds across shifts. Standardizing RPM may reduce variability.

Based on 1 similar deviations

Live Manufacturing Data

Live Monitoring

Temperature

Site A - Boston

37.2 °C

Target: 37.5

Pressure

Site A - Boston

1.2 bar

Target: 1.5

pH

Site A - Boston

7.1 pH

Target: 7.4

Temperature

Site B - Austin

36.8 °C

Target: 37.5

pH

Site B - Austin

6.7 pH

Target: 6.8

CAPA Effectiveness

Replace Gasket Material & Update PM ScheduleInProgress
Effectiveness Score0%
Filter Integrity Testing Protocol UpdateImplemented
Effectiveness Score95%