Integrated Quality Management
The Only eQMS Platform That Unifies Quality Processes and Training Compliance in One Integrated System
—
Experience the Power of Integrated Quality and Learning
See How Integration Transforms Quality Management
Join our live demo to discover how eLeaP QMS revolutionizes quality operations by seamlessly unifying quality management and learning in one powerful platform.
The Integration Advantage in Action
Automatic Training Deployment from Quality Events: When you create a CAPA in our Events module or update a controlled document, the system automatically triggers training assignments through our integrated Learning module. No manual handoffs. No data re-entry. No compliance gaps.
Document Control That Teaches: Your SOPs, Work Instructions, and Quality Procedures Aren’t Just Controlled—They’re Teachable. When documents reach Effective status, one click sends them to training with automatic assignment workflows, completion tracking, and comprehension verification.
Design Controls with Built-In Competency Management: As design requirements progress from User Needs through Verification and Validation, training requirements automatically cascade to the affected teams. Your Design History File includes complete training records, ensuring every team member is qualified for their role.
Risk-Based Training Assignment: When risk assessments identify new hazards or control measures, the system automatically generates targeted training for personnel affected by these changes. High-risk items trigger immediate training deployment with escalation workflows.
Complete QMS Capabilities You Need
Document Control
- Automated review and approval workflows with electronic signatures
- Version control with complete revision history
- Automatic training triggers when documents become effective
- Related items linking to CAPAs, risks, and design controls
- Configurable review cycles and expiration management
Events Management
- Configurable templates for CAPAs, deviations, audits, and investigations
- Phase-based workflows with review and approval gates
- Risk assessment integration with probability and severity scoring
- Task assignments with due date tracking
- Root cause analysis tools with effectiveness verification
Design Controls
- Full traceability from User Needs through Design Validation
- Column and row views for requirements management
- Design Review scheduling with approval workflows
- Traceability Matrix export for regulatory submissions
- Design History File generation with one-click PDF export
Risk Management
- ISO 14971-aligned risk analysis framework
- Interactive Acceptability Matrix with customizable scales
- Path to Harm visualization showing complete risk traceability
- Control measures tracking with residual risk calculation
- Integration with design controls and supplier management
Supplier Management
- Risk-based supplier classification and audit scheduling
- Configurable questionnaires and document requirements
- Supplier portal for self-service document uploads
- Audit management with e-signature capture
- Performance tracking with automated notifications
The Numbers That Matter
Lower Total Cost: Reduce costs with smart pricing for QMS and LMS fees from one vendor. Easy access to both platforms using built-in single sign-on.
Faster Implementation: Built on 20 years of proven LMS infrastructure with 164,000+ active users. Your QMS deploys on battle-tested technology.
100% Audit Ready: Complete 21 CFR Part 11 compliance with electronic signatures, comprehensive audit trails, and validated system documentation.
See It Work With Your Processes
Join our live demo, which showcases real workflows from medical device and life sciences companies:
- Change Control: Watch a document revision automatically trigger retraining for 500 users based on their roles and departments
- CAPA Management: See how corrective actions generate targeted training with effectiveness verification
- Design Transfer: Follow design output,s becoming training materials with automatic assignment to manufacturing teams
- Supplier Qualification: Track how supplier audits trigger training requirements for quality agreements
- Risk Mitigation: Observe risk control measures being deployed as preventive action training
Why This Integration Changes Everything
Traditional QMS platforms treat training as an afterthought—a checkbox to mark or a separate system to manage. eLeaP QMS embeds learning into every quality process:
- Review cycles automatically include training impact assessments
- Approval workflows route through training coordinators
- Task lists include training assignments with completion tracking
- Activity histories capture both quality actions and training completions
- Reports consolidate quality metrics with training effectiveness data
Ready to Transform Your Quality Operations?
Stop managing quality and training in silos. Stop paying for redundant systems. Stop explaining training gaps during audits.
Start streamlining compliance with integrated quality and learning. Start reducing costs while improving outcomes. Start with eLeaP QMS.
Join our live demo to see how forward-thinking medical device and life sciences companies achieve compliance without complexity.