About Us
Integrated Quality & Training Excellence Since 2005
The Only QMS with Enterprise LMS Built-In
For nearly two decades, eLeaP has served regulated industries with proven learning management solutions trusted by 1,544 organizations and over 164,000 users worldwide. Now, we’re transforming quality management by eliminating the costly disconnect between quality systems and training programs.
Purpose-Built for Regulated Industries
eLeaP Quality serves organizations that cannot compromise on compliance:
- Medical Device manufacturers (FDA 21 CFR Part 820, ISO 13485)
- Pharmaceutical and Biotechnology companies (21 CFR Part 11, ICH guidelines)
- Clinical Research organizations (GCP, GLP)
- Digital Health and Software as Medical Device (SaMD) developers
- Contract manufacturers and suppliers
- Nutraceuticals, Cosmetics, and Cannabis operations
Your Complete Quality Management System
Our comprehensive QMS modules address every aspect of your quality system:
- Document Management – Control documents and records with full audit trails
- Design Controls – Manage product development from concept through commercialization
- Risk Management – ISO 14971 compliant risk analysis and mitigation
- Change Control – Systematic change evaluation and implementation
- Events Management – CAPA, complaints, deviations, and non-conformances
- Supplier Management – Qualification, auditing, and performance monitoring
- Learning Management – Transform training from a compliance checkbox
The Integration Advantage
What sets eLeaP Quality apart is seamless integration between quality events and training requirements. When a deviation occurs, training is automatically triggered. When procedures change, affected personnel are immediately notified and enrolled in required training. This closed-loop system ensures:
- 100% training completion tracking for quality events
- Automatic competency verification before task assignments
- Real-time visibility into training gaps during audits
- Elimination of data silos between quality and training systems
Proven Compliance Framework
Our platform is built on 19+ years of experience helping organizations pass regulatory inspections:
- 21 CFR Part 11 compliant electronic signatures and records
- FDA QMSR Ready – Prepared for the February 2026 transition
- ISO 13485:2016 aligned quality processes
- Validated System with comprehensive IQ/OQ/PQ documentation
- Audit-Ready reporting and data integrity controls
Why Organizations Choose eLeaP Quality
Enterprise Capabilities at Mid-Market Pricing
We deliver the same functionality as MasterControl, Greenlight Guru, and Qualio at 60-70% less cost, making robust quality management accessible to organizations with 10-500 employees.
Implementation in Weeks, Not Months
Our pragmatic approach focuses on getting you operational quickly with core functionality, then expanding capabilities based on your specific needs.
Expert Support from Quality Professionals
Our team understands regulated industries. We speak your language and have helped hundreds of organizations achieve and maintain compliance.
Partnership, Not Just Software
eLeaP Quality represents more than software—it’s a commitment to your quality journey. We combine:
- Secure, scalable cloud infrastructure
- Intuitive interfaces that drive adoption
- Configurable workflows that match your processes
- Ongoing support from regulatory compliance experts
Join leading medical device manufacturers, pharmaceutical companies, and life sciences organizations who trust eLeaP to unify their quality management and training systems.
Ready to eliminate the gap between quality and training?
Contact us to see how eLeaP Quality can transform your approach to regulatory compliance while reducing your total quality system costs.