Stop FDA Compliance Failures Before They Cost You Millions
For 20 years, eLeaP® has been the trusted 21 CFR Part 11 LMS helping life science organizations eliminate audit risks and achieve regulatory excellence.
21 CFR Part 11 Compliant Learning Management System
Stop compliance failures before they cost your organization millions in fines, remediation, and lost reputation. eLeaP’s 21 CFR Part 11-compliant Learning Management System (LMS) eliminates audit risks and reduces compliance costs by 60% while delivering enhanced training management capabilities. We have meticulously designed our FDA-validated platform to exceed the stringent requirements set forth by the FDA, ensuring that your organization passes every regulatory audit effortlessly while fostering a bulletproof culture of continuous learning and quality excellence that drives measurable business results.
Key Features
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Electronic Signatures
Ensure ironclad authenticity and accountability with secure electronic signatures that guarantee 21 CFR compliance while providing complete audit traceability for every transaction.
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Robust Audit Trails
Never fail another audit with comprehensive tracking that records every action and access within the system, providing bulletproof audit trails that satisfy even the most stringent FDA inspections.
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Role-Based Access Control
Prevent unauthorized access and data breaches with intelligent role-based controls that safeguard sensitive information while ensuring only qualified personnel access critical compliance data.
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Document Management
Eliminate document chaos and version control nightmares by organizing all compliance documents securely within one system, ensuring instant access and perfect revision tracking that exceeds document control standards.
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Training Records Management
Turn audit preparation from months to minutes with centralized training records that automatically generate compliance reports and provide instant audit-ready documentation for any regulatory inspection.
eLeaP’s 21 CFR Part 11-compliant Learning Management System eliminates compliance risks while delivering exceptional learning outcomes that drive business results. Need GxP, Validation & Advisory services? For over 20 years, our proven platform has helped 500+ organizations cut compliance costs by 60% through seamlessly integrated electronic signatures, bulletproof audit trails, intelligent access controls, automated document management, and streamlined training record systems.
Why 500+ Life Science Companies Choose eLeaP’s 21 CFR Part 11 LMS
Smart organizations eliminate compliance risks while cutting costs by up to 60% with these proven advantages:
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Cost-Efficiency and Time Savings
Cut compliance costs by 60% and eliminate manual audit prep. Our LMS automates every compliance task, transforming weeks of preparation into minutes while eliminating costly human errors that trigger FDA citations.
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Global Accessibility and Scalability
Deploy compliance training globally in minutes, not months. Our enterprise-grade cloud infrastructure delivers instant worldwide access with unlimited scalability, supporting your organization’s growth from 50 to 50,000 users seamlessly.
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Enhanced Training Effectiveness
Increase training completion rates by 85% and knowledge retention by 40%. Interactive multimedia content, smart assessments, and AI-powered courses create engaging experiences that ensure critical compliance knowledge sticks.
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Regulatory-Grade Security Measures
Protect sensitive data with enterprise-grade security that exceeds FDA requirements. Bank-level encryption, continuous monitoring, and automated security updates provide comprehensive protection with SOC 2 compliance and 99.9% uptime guarantee.
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Tailored Learning Paths for Diverse Audiences
Deliver role-specific compliance training that reduces time-to-competency by 50%. Intelligent learning paths automatically adapt to job functions, ensuring technicians, managers, and executives get exactly the training they need to stay compliant.
Join 500+ life science organizations who trust eLeaP to streamline compliance and reduce audit risks. Experience proven regulatory compliance combined with measurable learning outcomes through our 20-year-tested 21 CFR Part 11-compliant LMS.
FDA-Validated LMS Platform
Experience the proven advantages and industry-leading capabilities of the eLeaP 21 CFR Part 11 platform.
Organizations achieve 100% audit readiness, reduce compliance costs by 60% through intelligent automation, maintain enterprise-grade data security, and deploy role-specific learning paths, ultimately ensuring bulletproof regulatory adherence while delivering measurable learning outcomes that drive business results.
Life Science Industry
In the rapidly evolving life sciences sector, regulatory failures can cost millions while innovation drives competitive advantage. For over 20 years, our 21 CFR Part 11-compliant learning management system has helped 500+ organizations eliminate compliance risks while accelerating growth. Here’s how:
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Regulatory Compliance
Maintain consistent compliance using validated electronic signatures, comprehensive audit trails, and role-based access control, ensuring adherence to stringent FDA regulatory requirements.
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Data Integrity Fortification
Protect sensitive information with robust document management that ensures secure storage, controlled access to critical documents, and complete data integrity throughout the system lifecycle.
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Training Precision
Improve training effectiveness through targeted learning experiences and comprehensive training records management that simplifies compliance reporting and audit preparation.
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Streamlined Operations
Reduce operational complexity with automated processes and seamless system integration that efficiently manages learning resources while minimizing compliance risks.
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Enhanced Security Protocols
Strengthen data security through enterprise-grade access controls, encryption measures, and regular security updates that protect the platform against potential threats.
Achieve reliable compliance and operational efficiency with eLeaP’s proven 21 CFR Part 11 LMS, where regulatory requirements meet practical innovation.
Why Choose eLeaP?
Understand the compelling reasons and unique advantages for selecting eLeaP as your learning solution.
We know you have choices when it comes to learning management systems or performance management platforms. Here’s why hundreds of companies have selected eLeaP. Here’s a hint, it is because of the value they derive each and every day from the system and service.
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Brand
For over 19 years, we’ve been sound financial stewards of our brand, plowing back resources into our platforms so that our customers can continue to benefit from our stability.
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Innovation
eLeaP uses a simple, minimalist but sophisticated philosophy which does not sacrifice innovation or breath for complexity and confusion.
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Trust/Reliability
We ensure that the platform is tested and validated in our live development instance before integration to our production services.
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Platform
Having one platform for managing online, in-person, instructor-led, e-commerce and extended enterprise learning and training is simply awesome.
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Extended Services
We know that many of you come for the learning management system but end up staying for the extensive services we offer.
Case studies: a track record of excellence
See the results of so many who have used the eLeaP system
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Maldivian Airlines
Maldivian, the national airline of the Maldives is the leading domestic carrier. Maldivian currently operates to India and Bangladesh from its main hub at Velana International Airport. Maldivian offer both...
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Bionical Solutions
Founded in 2001, Bionical Solutions is a pharmaceutical manufacturing company headquartered in Willington, Derbyshire, United Kingdom. The company provides clinical, commercial, and digital services to life sciences companies in the...
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Biorasi, LLC.
Headquartered in Florida, United States, with office-based teams around the globe, Biorasi is a global, award-winning and full-service contract research organization (CRO) that delivers the speed and agility that today’s...
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Natus Medical Incorporated
Founded in 1989, Natus Medical (Natus) is a medical equipment manufacturer based in the US. The company offers medical equipment, software, supplies, and services for diagnosing, monitoring, and treating impairments...