Deviation & CAPA Management
Get a unified view of quality events across TrackWise, Veeva, and other systems. Identify patterns, track investigations, and ensure CAPA effectiveness with cross-system visibility.
The cross-system quality challenge
Quality events are scattered across multiple systems, making pattern identification and trending nearly impossible.
Deviations in TrackWise, CAPAs in Veeva, notifications in SAP - no unified view.
Related events across systems go unconnected. Recurring issues stay hidden.
Days spent compiling quality metrics from multiple sources for management review.
Unified quality event management
Quality Event Tracking
Aggregate deviations, CAPAs, complaints, and quality notifications from all your systems into a single dashboard.
- Cross-system event feed
- Status tracking across systems
- Aging and SLA monitoring
Root Cause Analysis
Link related events across systems to identify true root causes. AI-assisted pattern recognition for recurring issues.
- Cross-system event linking
- Similar event identification
- Root cause categorization
CAPA Workflows
Monitor CAPA progress across systems with effectiveness tracking and automatic escalation for overdue actions.
- Unified CAPA tracking
- Effectiveness verification
- Escalation management
Trending and Analytics
Real-time quality metrics and trend analysis across all systems. Spot emerging issues before they become systemic.
- Cross-system trending
- Pareto analysis
- Management dashboards
Common use cases
Management Quality Review
Prepare for monthly quality reviews with automated roll-up of all quality events, trends, and metrics.
After: Real-time dashboard, always current
Recurring Issue Detection
Identify patterns across systems that indicate systemic issues requiring broader corrective action.
CAPA Effectiveness
Track whether corrective actions actually prevent recurrence by monitoring related events post-closure.
Audit Preparation
Quickly retrieve all quality events for a product, site, or time period with full investigation records.
Results you can expect
Quality metric compilation
Cross-system visibility
Better root cause analysis
Complete history
Unify your quality event management
See how BioWise brings together deviations and CAPAs from all your systems.
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