Quality Management System (QMS) for Regulated Industries
The Only eQMS Platform That Unifies Quality Processes and Training Compliance in One Integrated System
Enterprise Quality Management System for Regulated Industries
eLeaP is the only Quality Management System that seamlessly integrates Enterprise Learning Management into core QMS functionality. Unlike traditional platforms that require separate training systems, eLeaP automates competency management across all quality processes.
How It Works:
When SOPs are approved, they automatically become training assignments with completion tracking. Design changes cascade required training to affected teams. Risk assessments trigger mitigation training for identified hazards. Change orders prompt immediate retraining for impacted personnel. CAPAs and supplier audits drive targeted corrective training with effectiveness verification.Proven Results:
Our pre-validated platform enables deployment in weeks, not months. With built-in 21 CFR Part 11 compliance and templates for FDA, ISO, and ICH requirements, you’ll achieve audit readiness faster. Trusted by 164,000+ users across medical device, pharmaceutical, biotechnology, software, clinical research, cannabis, cosmetics, nutraceuticals, contract manufacturing and other life sciences companies worldwide.
FDA-Compliant Document Control with Integrated Training
Transform controlled documents into verified competencies. One click deploys SOPs as training with automatic assignment, tracking, and effectiveness measurement.
Enterprise Document Management Built for Quality Systems
Control your entire document lifecycle—from draft through obsolescence—with 21 CFR Part 11 compliant electronic signatures and audit trails. Manage SOPs, work instructions, forms, specifications, and policies with intelligent version control and automated approval workflows.
What Makes eLeaP Different:
Unlike traditional document control systems, eLeaP automatically converts approved documents into training curricula. When documents go effective, training deploys to affected roles instantly. Track read-and-understood acknowledgments, test comprehension, and maintain training matrices without spreadsheets. Learn more.
Design Controls with Built-In Competency Management
As design requirements progress through User Needs, Verification, and Validation, training automatically cascades to affected teams with complete traceability.
Your design control process is unique. eLeaP’s integrated design control module enables you to manage requirements from User Needs through Verification and Validation with full traceability to comply with ISO 13485 and the FDA’s QMSR. Create and manage design specifications, control their progression through phases, and maintain complete documentation for regulatory submissions.
Design control becomes the foundation for both product quality and team competency.
As design specifications progress through phases, training requirements automatically adjust. New requirements trigger training assignments. Design changes cascade training to affected teams. Design reviews create verification records. Generate Design History Files with complete training records, design reviews, and approval documentation for regulatory submissions. Requirements stay traceable. Teams stay competent. Compliance stays audit-ready. Learn more.
Integrated Risk Management
ISO 14971-aligned risk analysis with automatic training deployment when control measures change. The Path to Harm visualization provides complete risk traceability.
Corrective and Preventive Actions (CAPA) transform quality management into a strategic endeavor. eLeaP’s integrated risk management system turns quality incidents into learning opportunities by identifying root causes and ensuring corrective actions prevent recurrence. Conduct ISO 14971-aligned risk assessments with scoring for probability and severity, and deploy targeted training for new control measures.
Identify knowledge gaps, skill deficiencies, execution issues, or process failures
The system’s root cause analysis feature connects quality events to training history, assessments, and performance records, identifying knowledge gaps, skill deficiencies, execution issues, or process failures. Visualize Paths to Harm, monitor control effectiveness, and track CAPA status from initiation to closure. Identify patterns in root causes and utilize visual dashboards for continuous improvement. With eLeaP, every quality incident fosters systematic improvement based on competency and data. Learn more.
Change Management with Automatic Training
Document changes, design updates, and process modifications automatically trigger targeted training for affected personnel with escalation workflows
Process changes are inevitable, but training gaps don’t have to be. eLeaP’s change management automatically triggers training for teams with every document change and process update.
Manage change requests from initiation to implementation with tailored approval workflows.
Once changes are approved, employees receive customized training assignments based on their roles. Smart assignment rules help identify the right people for the right training, while learning paths guide them through the required content. Assessments ensure competency, and completion records remain audit-ready. This approach not only maintains operational efficiency but also turns change into an opportunity for continuous learning rather than a compliance risk. Learn more.
Quality Events Trigger Training Automatically
When you create a CAPA, deviation, or audit finding, the system automatically identifies training needs and deploys assignments through your integrated Learning module.
Training lapses pose compliance risks
eLeaP addresses this by automatically enrolling employees in training when quality events occur, eliminating manual errors and missed deadlines. CAPAs, deviations, and audit findings trigger real-time training assignments, ensuring no gaps in compliance.
Smart assignment rules identify suitable employees for relevant training based on their roles and responsibilities. Learning paths and assessments help employees meet the requirements, while records of completion are maintained for audits.
With training automation, compliance enhances operations rather than obstructs them, ensuring no missed training, no manual errors, and no audit gaps. Learn more.
Supplier Quality Management
Risk-based supplier classification, audit management, and performance tracking with automatic training triggers when supplier audits identify quality gaps.
Quality management extends beyond your facility with eLeaP’s supplier quality management module, which tracks supplier performance, audit results, compliance certifications, and quality issues throughout your supply chain.
Monitor supplier performance metrics, document audit results, and ensure compliance
When supplier quality issues arise, we can automatically initiate training for internal teams and maintain comprehensive audit trails for regulatory review.
By connecting supplier performance to your organization’s quality outcomes, you establish a cohesive quality system that integrates supply chain quality with team competency and overall organizational performance. Learn more.
Unified Learning & Quality. Close Compliance Gaps.
The trusted, integrated platform is purpose-built for regulated manufacturers and life sciences organizations, where training and quality work seamlessly as one system.
Quality management and training often operate in silos, leading to compliance blind spots. eLeaP integrates your QMS and LMS, allowing quality incidents to trigger training assignments and enabling real-time tracking of competency verification. This method promotes a culture of compliance through ongoing education and evaluates training effectiveness by assessing quality improvements.
When issues arise, the system automatically enrolls employees in necessary training and pinpoints whether problems stem from knowledge gaps or performance issues. Training completion updates compliance records, and competency assessments inform root cause analyses, ensuring nothing falls through the cracks.
This integrated process leads to quicker issue resolution, productive corrective actions, fewer audit findings, and measurable improvements in compliance. With eLeaP, continuous learning fosters quality excellence, establishing a seamless connection between quality and compliance.
Building a Culture of Compliance Through Integration
eLeaP creates quality systems that seamlessly integrate compliance into every workflow rather than adding it as an afterthought. Our integrated QMS empowers organizations to blend quality and learning effectively, making it easy to foster a culture of continuous improvement, competency verification, and data-driven decision-making for quality teams and regulatory leadership.
-
Automatic Training Triggers
Quality events, document changes, design updates, and risk assessments automatically deploy training to the right people at the right time, no manual assignments, no missed deadlines.
-
Integrated Competency Verification
Assessments verify knowledge in real-time. Training completion links directly to quality outcomes. Competency gaps inform root cause analysis and corrective actions.
-
Audit-Ready Compliance**
Complete audit trails connect quality decisions to training records. Compliance documentation maintains itself. Regulatory readiness becomes a natural outcome of integration.
Quality Excellence Through Integrated Learning
Compliance should empower teams rather than burden them. We simplify the process for quality leaders to eliminate compliance blind spots and help employees understand how continuous learning contributes to organizational success. Our integrated QMS provides powerful tools that enable teams to take ownership of quality improvements while giving quality leadership the insights and visibility needed to make data-driven decisions and support a sustainable compliance culture. Learn more.
-
Continuous Training Integration
Quality incidents automatically deploy targeted training. Design changes cascade learning requirements. Risk assessments trigger competency verification. Training is an essential component of every quality process.
-
Connected Quality Data
All seven modules, Documents, Design, Risk, Change, Events, Suppliers, and Learning, work as one system. No disconnected records. No manual handoffs. Complete audit trails.
-
Competency-Driven. Root Cause Analysis
Root cause analysis connects training completion, competency assessments, and quality outcomes. Identify whether issues stem from knowledge gaps, skill deficiencies, or process failures with confidence.
-
Here, When You Need Us
Do you have questions about implementing your QMS? Our quality experts are available to support your implementation, optimize your processes, and help you build a stronger compliance culture.