LMS

eLeaP's 21 CFR Part 11 Compliant Learning Management System is a purpose-built platform designed for FDA-regulated life science organizations. Unlike general LMS platforms adapted for compliance, eLeaP was architected from the ground up around 21 CFR Part 11 requirements, combining a Quality Management System (QMS) with learning management capabilities. The platform is intended for pharmaceutical manufacturers, contract research organizations, medical device companies, and other life science organizations that need to maintain audit-ready training records, validated electronic signatures, and complete audit trails at all times.

eLeaP has supported over 500 life science organizations since 2005, providing implementation, validation documentation, and ongoing compliance support. The platform addresses the most common audit failure points — hybrid paper-electronic environments, missing training records, unverifiable signatures, and inaccessible audit trails — by centralizing and automating compliance workflows in a single validated system.

Core Compliance Capabilities

• Electronic signatures: Built-in electronic signatures meet 21 CFR Part 11(a) and (b) requirements without third-party plugins, providing instant verification of who signed what and when.
• Automatic audit trail generation: Every system action is logged in real time with tamper-proof records, capturing who accessed training, when it was completed, scores achieved, who approved changes, and when documents were modified. Complete audit trails can be generated in under two minutes.
• Role-based access control: Defines and documents exactly who can access which records, with full documentation available for auditor review.
• Document version control: Tracks every document, every version, and every change, eliminating the need to search shared drives during inspections.
• Training compliance reporting: Generates complete training compliance reports for any employee in two clicks, replacing manual tracking and spreadsheets.

Training and Learning Management Features

• Observation assessments and OJT tracking: Natively tracks hands-on training through supervisor-led observation assessments and on-the-job training (OJT) records within the same system as online courses. Supervisors can complete checklists on mobile devices, with results automatically flowing into employee competency records and audit trails.
• AI-powered course creation: An AI Assistant reduces course development time by 70%, supporting content generation, translation into 22 languages, technical language simplification for different audiences, and adaptation of existing materials. Built-in accessibility checking ensures WCAG 2.1 compliance.
• Role-specific learning paths: Intelligent learning paths adapt to job functions, delivering targeted training for technicians, managers, and executives. This is reported to reduce time-to-competency by 50%.
• Skills and competency management: Tracks certifications, credentials, continuing education (CE), and role-specific competencies in a unified dashboard. Automatically triggers training when certifications near expiration, maps skills to courses, identifies competency gaps by role, and generates compliance reports showing qualifications by task — without requiring third-party integrations.
• Interactive multimedia content: Supports SCORM, smart assessments, and AI-powered courses designed to improve training completion rates and knowledge retention.

Security and Data Integrity

• Bank-level encryption and continuous monitoring protect sensitive data.
• Automated security updates and enterprise-grade access controls are included as standard.
• The platform maintains SOC 2 compliance and a 99.9% uptime guarantee.
• Robust document management ensures secure storage, controlled access, and complete data integrity throughout the system lifecycle.

Implementation and Validation

• Most organizations are fully operational within 30 to 60 days, following a phased process: system configuration (weeks 1–2), content migration and course setup (weeks 2–4), user training (weeks 4–5), and ongoing validation support.
• eLeaP provides GxP Validation and Advisory services, including a Validation Master Plan, System Requirements Specification, IQ/OQ/PQ protocols and reports, traceability matrices, risk assessments, change control procedures, and ongoing validation maintenance support.
• Comprehensive data migration is supported from legacy systems, spreadsheets, and other LMS platforms, preserving historical training records, completion dates, quiz results, certificates, user profiles, and audit trails with original timestamps and electronic signatures.
• A dedicated implementation specialist guides organizations through each phase, and a compliance team is available to support FDA audits directly.

Integration and Scalability

• Supports REST API for custom integrations and webhooks for real-time event notifications.
• Single Sign-On (SSO) is available with Azure, Okta, Google, and OneLogin, along with OAuth 2.0 authentication.
• Pre-built connectors include Slack, and the API supports automated user provisioning, course assignments, completion data syncing, and reporting integration with existing HRIS and ERP systems.
• Cloud infrastructure supports global deployment and scales from 50 to 50,000 users.

Support Options

• Dedicated implementation specialist during onboarding.
• Live customer support via phone, email, and chat during business hours.
• Comprehensive knowledge base, video tutorials, and regular compliance webinars.
• Quarterly business reviews for enterprise clients.
• Emergency audit support with priority response during FDA inspections.
• Enterprise Account customers receive a dedicated Customer Success Manager.

Pricing is based on active users and required modules. The base 21 CFR Part 11 LMS includes unlimited courses and learning paths, electronic signatures and audit trails, role-based access control, standard reporting and analytics, SCORM support, mobile access, and the AI course creation assistant. Optional add-on modules cover Skills Management, Credentials Management, E-commerce, Enterprise Account Management, SSO/OAuth, and GxP Validation Services.