Revision Controls for 21 CFR Part 11
Easily Track Training Course Changes
Overview of eLeaP’s Revision Controls
In highly regulated industries, managing electronic records with precision is not just best practice—it’s a requirement. eLeaP’s Revision Controls are specifically designed to meet the stringent requirements of 21 CFR Part 11, ensuring that every revision is tracked, controlled, and compliant.
Key Features
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Revision Controls
Automatic documentation of all changes, including who made the change, what was changed, and when it was done to support thorough audits and inspections.
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Robust Audit Trails
Track and record every action and access within the system, providing comprehensive audit trails for transparency and compliance.
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Electronic Signatures
Ensure authenticity and accountability with secure electronic signatures, meeting 21 CFR regulatory requirements while maintaining traceability.
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Role-Based Access Control
Defined access levels based on roles, safeguarding data integrity and ensuring confidentiality across the platform.
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Training Records Management
Streamline record-keeping with centralized training records management, simplifying compliance reporting and audits.
eLeaP’s 21 CFR Part 11-compliant Learning Management System provides a comprehensive solution that harmonizes regulatory compliance with unparalleled learning experiences. Need GxP, Validation & Advisory services? For over 19 years, our platform has streamlined compliance efforts by integrating electronic signatures, robust audit trails, role-based access control, document management, and training record management.
Why Use eLeaP’s Revision Control System?
With eLeaP’s Revision Controls, you gain more than just compliance. Enhance course quality, improve content accuracy, and ensure that all training materials meet the current regulatory standards without additional overhead or complexity.
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Cost-Efficiency and Time Savings
Streamline compliance processes and reduce manual efforts. Our platform automates compliance tasks, saving time and resources while reducing the risk of errors.
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Global Accessibility and Scalability
Enable critical learning from anywhere, anytime. With a cloud-based infrastructure, our platform ensures worldwide accessibility and scalability, to accommodate your needs.
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Enhanced Training Effectiveness
Elevate training effectiveness through interactive multimedia content, assessments, and real-time feedback, ensuring better knowledge retention and application.
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Improved Collaboration and Engagement
Foster collaboration and engagement among learners through forums, discussions, and collaborative projects, enhancing the overall learning experience.
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Regulatory-Grade Security Measures
Rest assured of top-notch security measures. Our LMS employs encryption, intrusion detection, and regular security updates, automatic back-ups to keep your data protected.
Join many industry leaders who trust eLeaP to revolutionize compliance and learning management. Experience the synergy of regulatory compliance and enhanced learning outcomes with our 21 CFR Part 11-compliant LMS.
FDA-Validated LMS Platform
Discover the inherent advantages and standout qualities of the eLeaP 21 CFR Part 11 platform.
Organizations benefit from reduced compliance risks, significant time and cost savings through automation, enhanced data security, and personalized learning paths, ultimately ensuring regulatory adherence without compromising on the quality of learning experiences.
Life Science Industry
In the rapidly evolving life sciences sector, compliance and innovation are the pillars of success. For over 19 years, our 21 CFR Part 11-compliant learning management system has supported organizations in the industry. Here’s how:
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Regulatory Compliance
Comply with mandates using electronic signatures, audit trails, and role-based access control, ensuring adherence to stringent regulatory requirements.
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Data Integrity Fortification
Safeguard sensitive information with robust document management, ensuring secure storage and easy access to critical documents while maintaining data integrity.
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Training Precision
Tailor learning experiences to suit diverse learner groups, enabling comprehensive training records management for compliance reporting and audits.
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Streamlined Operations
Optimize workflows and reduce compliance risks with automated processes, enabling seamless integration and efficient management of learning resources.
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Enhanced Security Protocols
Elevate data security through stringent access controls, encryption measures, and continuous updates, fortifying your platform against potential threats.
Experience a transformative shift in the life sciences landscape with eLeaP’s 21 CFR Part 11 LMS, where compliance meets innovation and growth knows no bounds.
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 that 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 into 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...