Reduce Quality Event Resolution Time by 70% While Strengthening Compliance
Transform scattered incident management into a unified system that captures, investigates, and resolves all quality events
The Events Management Problem:
- ❌ Quality events are tracked in disconnected spreadsheets and databases
- ❌ 41% of warning letters cite inadequate deviation and nonconformance handling
- ❌ Root cause investigations lack consistency and depth
- ❌ Events aren’t linked to trends, leading to repeated failures
The eLeaP Solution:
- ✅ 70% faster event resolution and closure
- ✅ Complete regulatory compliance for all event types
- ✅ Automated investigation workflows with root cause tools
- ✅ Real-time trending and predictive analytics
Stop managing quality events in silos that hide systemic issues. The Events Management module provides a centralized system for capturing, investigating, and resolving all quality events—deviations, nonconformances, complaints, adverse events, and more. Unlike fragmented approaches that miss connections between events, eLeaP delivers integrated event management that identifies trends and prevents recurrence. Start your free 30-day trial. No credit card required. Get full feature access and implementation support. Or schedule a free session with one of our solution experts.
Transforming Quality Event Management
Whether you’re handling production deviations, customer complaints, supplier nonconformances, or adverse events, effective event management is essential for maintaining quality and compliance. Traditional approaches using separate systems for different event types create blind spots that allow problems to escalate. eLeaP’s Events Management System provides complete visibility across all quality events.
At the core of eLeaP Quality Management Software is its powerful Events Management Module, a unified platform that handles all quality events through consistent, compliant workflows. With built-in investigation tools, automated escalations, and intelligent trending, eLeaP ensures events are resolved quickly while capturing valuable insights for continuous improvement.
Key Features
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Universal Event Capture
Log any quality event from a single interface—deviations, nonconformances, complaints, OOS/OOT results, adverse events, and more. Configure custom event types specific to your industry and processes.
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Intelligent Event Classification
Automatically categorize and prioritize events based on risk, impact, and regulatory requirements. Route critical events for immediate attention with automated notifications.
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Structured Investigation Tools
Guide investigations with built-in methodologies including 5 Whys, Fishbone diagrams, and Fault Tree Analysis. Ensure thorough root cause analysis with configurable investigation templates.
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Automated Workflow Management
Define stage-based workflows with automatic escalations for overdue tasks. Set review and approval requirements based on event severity and type.
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Integrated CAPA Linkage
Seamlessly escalate events to CAPA when systemic issues are identified. Maintain full traceability between events, investigations, and corrective actions.
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Cross-Functional Collaboration
Enable teams to work together with role-based access, task assignments, and automated notifications. Track investigation progress with real-time dashboards.
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Trend Analysis and Analytics
Identify patterns across events with configurable trending rules and statistical analysis. Use predictive analytics to prevent future occurrences.
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Supplier and Product Linkage
Connect events to specific products, lots, suppliers, or equipment. Track event history by source to identify problematic areas.
Why Select eLeaP Quality?
With deep expertise across pharmaceuticals, medical devices, diagnostics, and biotechnology, eLeaP understands that event management is where quality systems prove their value. Our unified approach eliminates the gaps between different event types while maintaining specific regulatory requirements for each. The integrated QMS+LMS platform ensures teams are trained on event handling procedures and investigation techniques.
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Resolve quality events 70% faster
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Identify trends before they become systemic issues
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Meet all regulatory reporting requirements
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Turn events into improvement opportunities
Proven Benefits:
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Faster Event Resolution
Reduce investigation and closure time from weeks to days with structured workflows and automated task management. Meet regulatory timeframes consistently.
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Reduced Recurrence Rates
Identify root causes effectively and implement lasting solutions. Decrease repeat events by 50% or more through systematic investigation and trending.
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Improved Compliance Posture
Eliminate observations related to deviation handling, complaint management, and adverse event reporting. Maintain inspection-ready documentation for all events.
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Lower Quality Costs
Prevent minor events from escalating into recalls, warning letters, or patient harm. Reduce investigation costs through standardized, efficient processes.
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Enhanced Risk Management
Use event data to update risk assessments and identify emerging hazards. Make proactive decisions based on real quality metrics.
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Better Supplier Performance
Track supplier-related events to drive improvement initiatives. Use objective data in supplier reviews and qualification decisions.
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Continuous Improvement Culture
Transform events from problems into learning opportunities. Build organizational knowledge through systematic capture and analysis of quality events.
The eLeaP Events Management Module is trusted by life sciences companies worldwide for its ability to transform reactive firefighting into proactive quality management. Take the next step toward comprehensive event management. Start your free trial below or schedule a demo today.
The Event Management Module is part of the comprehensive eLeaP Quality Management System.