Cut Change Control Cycle Time by 60% While Ensuring Full Traceability
Transform chaotic change management into a controlled system that accelerates improvements without compromising compliance
The Change Control Problem:
- ❌ Critical changes take weeks or months to implement
- ❌ 52% of recalls stem from inadequate change control procedures
- ❌ Impact assessments miss downstream effects on other processes
- ❌ Changes are implemented without proper effectiveness verification
The eLeaP Solution:
- ✅ 60% faster change implementation cycles
- ✅ Complete regulatory compliance (FDA, EU, ISO requirements)
- ✅ Automated impact assessments across all affected areas
- ✅ Real-time tracking with built-in effectiveness monitoring
Stop letting uncontrolled changes lead to deviations, recalls, and regulatory observations. The Change Control module provides a comprehensive system for managing all changes—from minor documentation updates to critical process modifications. Unlike paper-based systems or basic workflows that create bottlenecks, eLeaP delivers intelligent change management that balances speed with control. 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 Change Management for Regulated Industries
Whether you’re updating manufacturing processes, modifying product designs, or revising quality procedures, effective change control is critical for maintaining validated states and regulatory compliance. Traditional approaches using paper forms, email approvals, and disconnected tracking create delays, gaps, and compliance risks. eLeaP’s Change Control System delivers efficiency without sacrificing control.
At the core of eLeaP Quality Management Software is its powerful Change Control Module, an intelligent system that manages the complete change lifecycle from request through implementation and effectiveness checks. With configurable workflows, automated impact assessments, and integrated training updates, eLeaP ensures changes improve your operations while maintaining compliance.
Key Features
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Intelligent Change Classification
Automatically categorize changes based on risk and impact—minor, major, or critical. Apply appropriate controls and approval requirements based on change type and affected systems.
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Comprehensive Impact Assessment
Evaluate effects across products, processes, equipment, and documentation. Identify all affected procedures, specifications, and validated systems with automated dependency mapping.
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Configurable Approval Workflows
Design multi-level approval chains based on change classification and functional areas. Enable parallel reviews to accelerate approvals while maintaining proper oversight.
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Cross-Functional Change Boards
Facilitate change control board (CCB) reviews with automated scheduling, participant notifications, and decision documentation. Track action items and conditional approvals.
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Implementation Planning and Tracking
Create detailed implementation plans with tasks, responsibilities, and timelines. Monitor progress with real-time dashboards and automatic escalations for overdue items.
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Integrated Training Management
Automatically trigger training requirements when changes affect procedures or processes. Track completion before implementation and maintain training effectiveness records.
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Validation and Qualification Support
Link changes to validation protocols and qualification requirements. Ensure validated states are maintained for equipment, processes, and computerized systems.
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Effectiveness Monitoring
Identify changes requiring regulatory notification or approval. Generate submission packages with all supporting documentation and maintain approval records.
Why Select eLeaP Quality?
With over 20 years serving life sciences companies, eLeaP understands that change control must enable continuous improvement while maintaining control. Our system adapts to your specific needs—whether you’re managing changes to medical devices, pharmaceutical processes, clinical protocols, or laboratory methods. The integrated QMS+LMS platform ensures all affected personnel are trained before changes go live.
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Accelerate change implementation by 60% or more
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Maintain complete traceability and compliance
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Prevent changes from causing deviations or recalls
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Enable continuous improvement with confidence
Proven Benefits:
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Faster Time to Market
Implement product improvements and process optimizations quickly with streamlined approvals and parallel reviews. Reduce change cycle time from months to weeks.
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Reduced Compliance Risk
Eliminate observations related to inadequate change control with complete documentation, proper impact assessments, and effectiveness verification.
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Prevention of Quality Events
Identify potential issues before implementation through comprehensive impact analysis. Reduce deviations, complaints, and nonconformances caused by changes.
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Improved Operational Efficiency
Enable continuous improvement by removing barriers to beneficial changes. Implement best practices and lessons learned across sites and products.
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Enhanced Visibility and Control
Track all changes in one system with real-time status updates and comprehensive reporting. Identify trends and bottlenecks to optimize change processes.
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Successful Regulatory Inspections
Demonstrate robust change control with complete documentation, clear rationale, and evidence of effectiveness. Show regulators that changes are managed systematically.
The eLeaP Change Control Module is trusted by pharmaceutical, medical device, and biotechnology companies worldwide for its ability to accelerate improvements while maintaining control. Take the next step toward efficient, compliant change management. Start your free trial below or schedule a demo today.
The Change Control Management Module is part of the comprehensive eLeaP Quality Management System.