Solution

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.

Quality Events Dashboard
12
Open Deviations
8
CAPAs In Progress
3
Pending Review
47
Closed This Month
DEV-2026-0847
TrackWise
CAPA-2026-0234
Veeva
QE-2026-0512
SAP QM

The cross-system quality challenge

Quality events are scattered across multiple systems, making pattern identification and trending nearly impossible.

Silos
Disconnected systems

Deviations in TrackWise, CAPAs in Veeva, notifications in SAP - no unified view.

Blind spots
Missed patterns

Related events across systems go unconnected. Recurring issues stay hidden.

Manual work
Reporting burden

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.

Before: 3-5 days of manual compilation
After: Real-time dashboard, always current

Recurring Issue Detection

Identify patterns across systems that indicate systemic issues requiring broader corrective action.

Example: Similar packaging deviations across 3 products traced to common supplier change

CAPA Effectiveness

Track whether corrective actions actually prevent recurrence by monitoring related events post-closure.

Key metric: Recurrence rate within 12 months of CAPA closure

Audit Preparation

Quickly retrieve all quality events for a product, site, or time period with full investigation records.

Benefit: Instant access to complete quality history during inspections

Results you can expect

80%
Faster reporting

Quality metric compilation

3x
Better pattern detection

Cross-system visibility

45%
Reduced recurrence

Better root cause analysis

100%
Audit trail

Complete history

Unify your quality event management

See how BioWise brings together deviations and CAPAs from all your systems.

Request Demo