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Integrated quality management and training automation for regulated industries, with 21 CFR Part 11 compliance and real-time competency tracking.

Solution by eLeaP
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Overview

eLeaP is a combined Quality Management System (eQMS) and Enterprise Learning Management System (LMS) built for regulated industries including pharma, medical device, aerospace, and manufacturing. The platform has been in operation for over 20 years and is validated to 21 CFR Part 11 standards. It can be deployed as a standalone LMS or standalone QMS, or used as a unified platform where quality events and training compliance are directly connected. A Performance Management module is also available as an additional component.

The platform is designed for organizations that need to maintain audit-readiness, automate compliance documentation, and link quality decisions to employee training records. eLeaP serves over 1,393 active companies across 197 countries and has supported more than 7.6 million learning development sessions.

Quality Management System (eQMS) Capabilities

  • Document control with revision control and electronic signatures
  • Design control and change management
  • CAPA (Corrective and Preventive Action) tracking
  • Deviation management
  • Risk management
  • Supplier management
  • Audit preparation and management
  • Complete audit trails connecting quality decisions to training records
  • When SOPs or documents change, training assignments deploy automatically to affected employees

Enterprise Learning Management System (LMS) Features

  • 21 CFR Part 11-compliant platform with built-in electronic signatures
  • Smart Assignment rules for automated training assignment
  • Customized Learning Paths
  • Skills and Competency tracking
  • Observation Assessments
  • On-the-Job Training (OJT) management
  • Revision control for training materials
  • Automated reporting and compliance documentation
  • Real-time visibility into training status across all quality processes

Automated Compliance Training

  • Quality events such as document changes, CAPAs, and deviations automatically trigger employee training assignments
  • Automated completion tracking and documentation maintained in real time
  • Compliance records kept current and available for regulatory review without manual intervention
  • System identifies whether quality issues stem from knowledge gaps, skill deficiencies, or process failures

Performance Management

  • Connects employee competency data to performance outcomes
  • Integrated assessments and customizable performance reviews
  • Real-time performance tracking aligned with compliance requirements
  • When quality events occur, competency data supports root cause identification and informs targeted training to prevent recurrence
  • Skill tracking and performance reviews work together to close the loop between individual performance and quality outcomes

Training Content Library

  • Thousands of professional video training courses and curated course packages
  • Topics include Health and Safety, HR Compliance, Communication Skills, PC Skills, Leadership, Customer Service, Team Building, and Management and Supervision
  • Compliance: 114 courses
  • Computer Skills: 81 courses
  • Conflict: 139 courses
  • Harassment Prevention: 38 courses
  • Content library integrates directly into the LMS for immediate employee access

Deployment and Support

  • Pre-validated platforms built on 20 years of proven infrastructure
  • Designed for rapid deployment — up and running in a short setup period
  • Free 24/7 customer support included
  • Transparent, upfront pricing model
  • Scales from growing businesses to global enterprises

eLeaP is validated and audit-ready out of the box, with a single secure dashboard providing real-time quality records, training completion data, and compliance reports. The platform is designed to meet the compliance demands of global regulatory standards while supporting rapid adoption across regulated organizations at any stage of growth.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechMedical Devices
Development stage(s)
ClinicalManufacturingPost-Market & RWEPreclinical / Pre-Market
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP