Reduce Risk-Related Observations by 90% While Accelerating Product Development
Transform reactive risk management into a proactive system that ensures patient safety and regulatory compliance
The Risk Management Problem:
- ❌ Risk assessments become outdated documents that don’t drive decisions
- ❌ 68% of warning letters cite inadequate risk management procedures
- ❌ Teams struggle to maintain living risk files across product lifecycle
- ❌ Risk controls aren’t verified or monitored post-implementation
The eLeaP Solution:
- ✅ 90% reduction in risk-related regulatory observations
- ✅ Complete compliance with ISO 14971, ICH Q9, and FDA requirements
- ✅ Automated risk monitoring with real-time updates
- ✅ Integrated risk controls across design, production, and post-market
Stop treating risk management as a checkbox exercise. The Risk Management module provides a living system that integrates risk analysis throughout your quality processes—from initial hazard identification through post-market surveillance. Unlike static risk documents that gather dust, eLeaP delivers dynamic risk management that evolves with your products and drives real safety improvements. 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 Risk Management for Life Sciences
Whether you’re developing medical devices, pharmaceuticals, biotechnology products, or diagnostics, effective risk management is essential for patient safety and regulatory compliance. Traditional approaches using static FMEAs and isolated risk assessments fail to capture the dynamic nature of risk throughout the product lifecycle. eLeaP’s Risk Management System creates a living framework that grows with your products.
At the core of eLeaP Quality Management Software is its powerful Risk Management Module, a comprehensive system that adapts to your specific regulatory framework and product portfolio. With support for multiple risk methodologies, automated risk scoring, and seamless integration across quality processes, eLeaP ensures your risk management activities add value beyond compliance.
Key Features
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Flexible Risk Frameworks
Configure the system for ISO 14971 (medical devices), ICH Q9 (pharmaceuticals), or custom frameworks. Support FMEA, FTA, HAZOP, and other methodologies with built-in templates and scoring matrices.
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Comprehensive Hazard Identification
Build and maintain hazard libraries with categories for biological, chemical, physical, and usability risks. Link hazards to similar products and leverage historical data for comprehensive analysis.
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Dynamic Risk Assessment
Calculate risk scores automatically based on severity, occurrence, and detectability. Configure custom scoring matrices and acceptability thresholds based on product classification and intended use.
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Risk Control Management
Define and track risk controls with clear implementation requirements and verification methods. Maintain traceability between hazards, controls, and residual risk evaluations.
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Benefit-Risk Analysis
Document and maintain benefit-risk profiles for products. Support complex analyses for combination products, high-risk devices, and novel therapeutics with clear justifications.
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Cross-Functional Integration
Link risks directly to design controls, CAPAs, complaints, and nonconformances. Automatically trigger risk reassessment when quality events occur or changes are implemented.
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Risk Communication Tools
Generate risk management reports, summaries, and disclosures for regulatory submissions. Create risk-benefit communications for healthcare providers and patients.
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Automated Risk Reviews
Schedule periodic risk reviews with automated notifications and escalations. Track risk trends over time and identify emerging patterns before they become critical.
Why Select eLeaP Quality?
With expertise across medical devices, pharmaceuticals, and biotechnology, eLeaP understands that risk management must be practical, not just compliant. Our system integrates risk thinking throughout your quality processes, from initial development through post-market surveillance. The combined QMS+LMS platform ensures teams understand and consistently apply risk management principles.
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Meet ISO 14971, ICH Q9, and FDA risk requirements
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Reduce risk-related observations by 90% or more
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Integrate risk management across all quality processes
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Make risk-based decisions with confidence
Proven Benefits:
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Faster Regulatory Clearances
Submit comprehensive risk management files that meet regulatory expectations for FDA, EU, and other markets. Demonstrate thorough risk analysis and appropriate controls.
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Reduced Product Liability
Document comprehensive risk assessments and control measures that demonstrate due diligence. Maintain defensible records of risk-based decisions throughout product lifecycle.
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Lower Operational Costs
Focus resources on high-risk areas through data-driven prioritization. Reduce over-engineering of low-risk aspects while ensuring critical risks are controlled.
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Enhanced Decision Making
Make informed risk-based decisions for design changes, supplier selections, and process modifications. Balance risk and benefit with clear documentation and rationale.
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Streamlined Audits
Demonstrate mature risk management with comprehensive documentation, clear traceability, and evidence of continuous improvement. Show regulators that risk drives your quality decisions.
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Proactive Risk Mitigation
Identify potential failures before they occur through systematic analysis. Implement preventive measures based on risk priority rather than reacting to problems.
The eLeaP Risk Management Module is trusted by life sciences companies worldwide for its ability to transform risk management from a regulatory burden into a competitive advantage. Take the next step toward proactive, value-driven risk management. Start your free trial below or schedule a demo today.
The Risk Management Module is part of the comprehensive eLeaP Quality Management System.