The Only QMS with Enterprise Learning Management System
Documents, Design Controls, CAPAs, Risk, Change Control, Suppliers—unified with training for true FDA readiness.
FDA-Ready Document Control with Built-In Training Records
21 CFR Part 11 compliant document management. Uniquely tracks training completion for every controlled document.
Design Controls That Accelerate Regulatory Submissions
Manage your complete DHF with built-in training records. Prove design competency for faster regulatory approval.
Enterprise Risk Management with Built-In Controls
Support ISO 14971, ICH Q9, and FMEA methodologies. Risk mitigations cascade to mandatory training assignments.
Change Control That Prevents Compliance Drift
Complete change lifecycle with risk assessment. Automatic retraining ensures changes don’t break compliance.
Strengthen Supplier Management with Risk-Based Oversight
Automate qualification and audit schedules. Gain real-time visibility into vendor performance and compliance.
Centralize and Automate CAPAs, NCRs, and Quality Events
Manage NCRs, RCAs, and CAPAs in one place. Trigger training instantly to resolve gaps and ensure compliance.
Enterprise Quality Management System (QMS) Software for Regulated Industries
Complete QMS platform with integrated Learning Management System (LMS) for medical device, pharmaceutical, and life sciences companies
What is eLeaP QMS?
eLeaP is a comprehensive quality management system that uniquely integrates enterprise learning management capabilities in one unified platform. Unlike standalone QMS solutions, eLeaP automatically connects quality processes to training verification—eliminating compliance gaps between your QMS and training records.
Complete QMS Modules with Training Integration:
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Document Control
21 CFR Part 11 compliant document management with automatic SOP training deployment
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Design Controls
Design History File (DHF) management where design changes trigger competency assessments
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Risk Management
ISO 14971, ICH Q9, and FMEA methodologies with mitigation training tracking
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Change Control
Engineering change orders (ECO/ECN) with automatic retraining for affected personnel
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CAPA Management
Corrective and preventive actions with effectiveness verification through training
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Event Management
Complaints, nonconformances (NCR), and deviations with root cause training
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Supplier Management
Vendor qualification and audit findings that drive corrective training assignments
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Regulatory Compliance & Standards
Our FDA-compliant QMS software supports 21 CFR Part 11 (electronic signatures), 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, ISO 9001:2015, ICH guidelines, EU MDR, and cGMP requirements. Pre-validated for life sciences with built-in compliance templates and audit trails.
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Proven Results
With 20 years serving regulated industries and 1,544 companies served, eLeaP helps medical device manufacturers, pharmaceutical organizations, biotechnology companies, and clinical research organizations achieve faster regulatory submissions, reduce quality events by up to 40%, and maintain continuous audit readiness—all while reducing total quality management costs by 60-70% compared to enterprise alternatives.
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Industries Served
Medical Devices, Pharmaceuticals, Biotechnology, Enterprise Software, Digital Health & SaMD, Clinical Research, Regulated Cannabis & Hemp, Cosmetics & Personal Care, Nutraceuticals, Contract Manufacturing (CMO/CDMO), Quality & Regulatory Affairs.
Document Control with Automatic Training Deployment
Manage SOPs, work instructions, forms, and quality procedures with 21 CFR Part 11 compliant document control. Full lifecycle management includes version control, approval workflows, and effective dating. Uniquely, approved documents automatically become assigned training with completion tracking. Monitor who needs training, who’s completed it, and maintain comprehensive audit trails. Eliminate spreadsheet tracking while ensuring every document revision triggers required retraining for affected personnel.
Design Controls with Complete Training Traceability
Manage design and development from concept through commercialization with ISO 13485 and FDA-compliant design controls. Track requirements, specifications, verification, and validation with full traceability matrix. Build comprehensive Design History Files (DHF) including design inputs, outputs, reviews, and transfer documentation. Uniquely, training requirements cascade automatically through design phases—when specifications change, affected engineers and technicians are notified and retrained. Generate submission-ready documentation with integrated competency records for faster 510(k), PMA, and CE mark approvals.
Integrated Risk Management with Automated Mitigation Training
Bridge the gap between risk identification and prevention. eLeaP supports ISO 14971 (MedTech), ICH Q9 (Pharma), and FMEA methodologies in one unified platform. Conduct comprehensive assessments using customizable probability and severity matrices, generate risk priority numbers, and track residual risks in real-time.
Unlike siloed tools, eLeaP automatically deploys targeted training the moment new control measures are identified. Visualize Paths to Harm, maintain living risk registers, and ensure every mitigation strategy includes verifiable proof of competency for your next inspection.
Adaptive Event Management with Custom Workflow Templates
Stop forcing your quality processes into rigid software silos. eLeaP’s powerful customizable templates allow you to build tailored workflows for CAPAs, NCRs, deviations, RCA investigations, and any other quality event unique to your industry. From initiation to closure, you control the data fields, approval logic, and containment steps to match your specific SOPs.
Integrated Operations: Change, Suppliers, Templates & Learning.
Bring speed and precision to your core quality ecosystem by centralizing the lifecycle of your most critical operations. eLeaP provides a high-visibility hub to manage Change Control for document and process modifications, alongside Supplier Management for tracking audits and quality agreements.
The engine behind this flexibility is our Customizable Templates, allowing you to build industry-specific logic for any quality event—from AI-powered SOP generation to unique vendor qualification workflows. Unlike disconnected systems, these modules are natively linked to our Integrated Learning Management engine. This ensures that any operational shift—whether a document change or a supplier update—automatically triggers targeted retraining and competency tracking for affected teams, guaranteeing a continuous state of audit-readiness.
You’re at the heart of our commitment to Compliance, Integration, and Audit Readiness.
eLeaP delivers a user-friendly QMS with seven core modules covering documents, design, risk, change, quality events, suppliers, and learning. Training is automated to address compliance gaps, convert documents into learning tools, and trigger retraining based on changes, audits, or events, using quick-deploy templates to ensure teams can focus on continuous improvement.
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See Your Complete Quality Status
Real-time visibility across documents, design, risk, change, events, suppliers, and learning. Training links to every quality action. One platform. One sign-on. One source of truth.
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Compliance Without Manual Work
Approved documents trigger training. Design, risk, and change updates cascade requirements. Events and audits close gaps. Learning tracks completion, no handoffs.
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Connected Data Drives Better Decisions
All seven systems: Documents, Design, Risk, Change, Events, Suppliers, Learning, operate as one integrated QMS. Root cause analysis links training and performance data to every audit trail.
Trusted by Regulated Industries for 20+ Years
Medical device, pharmaceutical, biotechnology, and healthcare organizations trust eLeaP for critical compliance. Built on 20 years of proven infrastructure supporting 164,000+ users, our platform embeds compliance into daily workflows—not as an afterthought. Whether in software development, clinical research, contract manufacturing (CMO/CDMO), or aerospace teams can focus on quality improvement while the system ensures no requirement is overlooked. The platform is fully 21 CFR Part 11 compliant, providing complete audit trails and validated documentation.
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.