Services
Most organizations run quality and training on separate platforms that were never designed to talk to each other.
FDA-Validated Quality Management System
Complete quality lifecycle management for regulated industries
eLeaP’s QMS platform delivers the full complement of quality processes required by FDA-regulated manufacturers, life sciences organizations, and medical device companies. Built with 21 CFR Part 11 compliance natively — not bolted on — the system generates the audit trail, electronic signature, and record-keeping infrastructure that FDA and ISO auditors expect to see. Learn more here.
Delivering on your quality promise
The platform can be deployed standalone or as part of eLeaP’s unified QMS + LMS architecture. For organizations that are consolidating vendors or replacing a QMS that lacks training integration, the unified deployment is the stronger option: quality records and training records coexist in the same validated environment.
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Document Control
Version-controlled SOPs, work instructions, and policies with controlled distribution and acknowledgment tracking
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Design & Development
Phase-gated design and development workflows aligned to ISO 13485 Section 7.3, QMSR, and AS9100 requirements, with design history file documentation and automatic training deployment as development phases progress
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CAPA Management
Root cause analysis, corrective and preventive action workflows, effectiveness verification, and closure criteria tied to training completion
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Deviation and Nonconformance Management
Capture, investigation, disposition, and recurrence tracking against 21 CFR Part 820 as amended by QMSR and ISO 13485 Section 8.3 requirements
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Audit Management
Plan, execute, and close internal quality audits, supplier audits, and GMP compliance audits with ISO 19011-aligned workflows — structured findings linked directly to corrective actions, with training gap identification triggering workforce training assignments and verified closure tracking
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Event Management
Unified management of audits, CAPAs, nonconformances, and deviations in a single closed-loop workflow — from capture and investigation through disposition, effectiveness verification, and recurrence tracking
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Change Control
Management of Change (MOC) workflows with impact assessment, approval routing, and automatic retraining triggers when procedures are revised
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Audit Trail
Immutable, time-stamped records of every system action, meeting 21 CFR Part 11 Section 11.10(e) requirements
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Supplier Quality Management
Approved supplier lists, qualification records, and audit scheduling
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Risk Management
Risk assessment documentation aligned to ISO 14971 for manufacturers
Learning Management System
Enterprise training management with the compliance depth regulated industries require.
eLeaP’s LMS heritage goes back more than two decades — it predates the QMS capabilities and reflects the organizational learning DNA that defines how the platform approaches training management. This is not a compliance checkbox bolted onto a QMS. It is a full enterprise learning system that handles the full spectrum from onboarding to recertification to skills development, with the compliance infrastructure regulated industries require built throughout.
The defining characteristic of eLeaP’s LMS in a regulated-industry context is its native integration with quality events. Most LMS platforms require an API connection to a QMS to create this functionality — and API integrations create validation obligations, data synchronization risks, and points of failure. eLeaP eliminates those risks because the connection is internal, not architectural.
Platform Capabilities:
- Automated Training Assignment — training modules triggered automatically by CAPA events, document revisions, role changes, or scheduled recertification cycles
- Compliance Documentation and Reporting — 21 CFR Part 11-compliant electronic training records with audit-ready reporting for FDA inspections and ISO audits
- Certification and Recertification Management — expiration tracking, automated re-enrollment, and gap reporting before compliance deadlines
- Learning Paths and Teams — structured curriculum sequences tied to job functions, compliance requirements, or competency frameworks
- Virtual Classroom and Blended Learning — instructor-led training scheduling alongside self-paced eLearning within a single record
- Mobile Learning Access — device and browser-agnostic delivery for manufacturing floor and field-based workforces
- Skills Gap Analysis — competency mapping against role requirements with visibility into where gaps exist before they become audit findings
- On-the-Job Training Modules — structured OJT documentation with supervisor sign-off and evidence capture
- Advanced Tracking and Reporting — custom report builder, automated notifications, and dashboard views for training coordinators and QA managers
- Multiple Account Management — support for multi-site organizations, franchise operations, and companies managing training for external partners or customers
Training Course Library
Compliance and skills content ready to deploy — no build time required.
eLeaP maintains an extensive library of ready-to-deploy training courses covering compliance requirements, workplace safety, professional skills development, and industry-specific topics. Courses include learning content, assessment quizzes, and instructor notes, and are delivered through the same LMS environment — no separate content platform to manage.
Courses are priced starting at $19.95 per year, with volume discounts for course bundles and user counts that make library deployment cost-effective at scale. Organizations that need specific compliance courses not in the standard library can access eLeaP’s custom content development program.
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Cost effective
Our courses start at $19.95 per year with generous discounts for course and user bundles. Value is unmatched.
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Experience
We have experience providing great content to clients since 2005. Our process is easy and seamless and you have a chance to work with a customer-centric team.
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World class Support
Content is only as good as the user-experience. You and your users can rely on us to make sure access is quick and easy.
Custom eLearning Content Development
Organization-specific training content built to your SOPs, your processes, your workforce.
Off-the-shelf compliance courses cover the regulatory framework. Custom content covers the specific procedures, equipment, processes, and institutional knowledge that make your operation function. eLeaP’s content development team has been building custom eLearning since 2005, working with organizations across regulated manufacturing, aviation, healthcare, and professional services. We have helped many companies like Maldivian Airlines, Tanco Engineering, and Sentinel Security develop engaging and interactive e-Learning training courses for customers and staff with our Custom Content Development Program. Get started with your custom content development project here.
Your subject matter experts or our own research
The development process accommodates both pathways: eLeaP can work from your subject matter experts’ input and existing documentation, or independently research and develop content for topics where internal expertise needs supplementing. Output is device and browser-agnostic, with no compatibility dependencies on your end.
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Instructional design
Content architecture based on adult learning principles, with measurable learning objectives and assessment design
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Visual and interactive content
Video, animation, scenario-based learning, branching simulations, and interactive diagrams
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Audio narration
Professional or ai voiceover recording narration and audio components to make your presentation pop.
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Technology platform
Content developed to ensure systems are smooth and error-free with adequate troubleshooting resources for users.
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Device, browser agnostic
The content developed can be seamlessly viewed on any device and in any browser.
Performance Management
Close the loop between training, competency, and individual performance.
Most organizations track training completion and performance separately. A training record shows a course was completed; a performance review assesses how well the person is doing their job. But the connection between the two — did the training actually build the competency? is the competency gap showing up in performance? — is rarely visible in a way that managers can act on.
eLeaP’s Performance Management system creates that connection. Training data, competency records, and performance metrics coexist in the same environment, so the relationship between them is visible. Managers can see not just that an employee completed GMP training, but whether the competency it was meant to build is reflected in their performance data.
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Cost effective
The eLeaP Performance Management system is priced to fit your budget. With an ever-expanding toolkit, you will continue to maximize your investment.
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Experience
For over 20 years, eLeaP has been helping organizations strengthen systems and improve performance while providing stellar support to all, including your end-users.
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White-glove Support
Quickly access live support agents, support videos, user guides, quick tips, and resources to ensure successful implementation and outcomes.
Getting Started with eLeaP
Pricing is structured to scale: the training course library starts at $19.95 per user per year, with bundle discounts for larger user counts and multi-course deployments. Platform pricing for QMS and LMS is available upon request and is configured based on organizational size and module selection.
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30-minute session
Request a 30-minute product demonstration with an eLeaP implementation specialist
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Explore
Explore the integrated QMS + LMS architecture in depth
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Contact
Contact the team at (877) 624-7226 or sales@eleapsoftware.com for pricing and implementation timelines
See what our clients say about us
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Thank you for all your help. I’m really pleased with how easy it is to set up courses, upload content and assign users in eLeaP.
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The eLeaP training system is very user-friendly, and it significantly improved our current training process. The thing that was most impressive to me was the customer service. It’s very rare that a CEO would take the time to sit with a client and help them with their every need.
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Wow! Thank you so much. Your eLeaP service has been amazing.