Quality Management System (QMS)
Trusted for 20+ years. The quality management system (eQMS) with integrated learning management (LMS).
Streamline Your Quality Management Without the Complexity
Sync Documents. Analyze Risk. Go Live Today.
Managing complex quality standards shouldn’t be a burden. We designed our eQMS to be intuitive yet powerful, allowing you to centralize document control, training management, risk assessments, and CAPAs in one place. Quickly digitize your quality processes using our AI Assistant or import existing SOPs, ISO standards, and validation protocols with full version control and audit trails built right in. Book a quick demo.
All the tools you need to manage and automate your compliance
Design and centralize sophisticated quality processes utilizing document control, automated workflows, and CAPA tracking. Manage SOPs, design controls, risk assessments, change controls, and supplier quality in one unified environment. You can also create automated validation tests and quizzes to verify competency, ensuring your team follows strict progression rules and stays audit-ready at all times. eLeaP is the only eQMS with built in learning management and performance.
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Centralize Quality Documentation
Effortlessly upload SOPs, validation protocols, and design files. Supports all formats including PDF, CAD drawings, and Office docs with full version history built-in.
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Streamline Compliance Workflows
Create distinct quality paths to route documents for review and approval. Ensure the right teams have instant access to the latest approved revisions.
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Conduct Internal Audits & RCA
Quickly generate digital audits and assessments to identify gaps. Use root cause analysis tools to understand non-conformances and ensure total quality.
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CAPA & Event Management
Trigger automated alerts for pending actions and quality events. Document results in real-time, collect electronic signatures, and maintain a permanent audit trail.
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Mitigate Risk with Intelligent Data
Use risk matrices and dashboards to identify trends before they become issues. Smart reporting tools save hours of manual data prep for your next inspection.
Enterprise-Grade Compliance Visibility
FDA 21 CFR Part 11, ISO 13485, ISO 9001, GxP, Audit Trails
Automate CAPA, Non-conformances (NCR), and Change Control within a single, unified source of truth. Schedule, track, and document every quality event with powerful automatic notifications, smart escalation rules, and real-time reporting. eLeaP is a fully validated system designed specifically for regulated environments, ensuring your audit trails are immutable and your quality data is always ready for inspection.
Total Visibility Across Your Entire Quality System
Stop chasing data across spreadsheets. Automatically aggregate information on document control, internal audits, and quality events for comprehensive oversight. Whether you are preparing for an ISO audit or a routine FDA inspection, our reporting tools ensure your data is accurate, validated, and ready to present at a moment’s notice.
Stay Compliant with Industry Regulations
Deploy a pre-validated QMS built for rapid implementation
FDA 21 CFR Part 11 sets the standard for secure electronic records and signatures. An integrated Quality Management System ensures your digital audit trails are immutable, trustworthy, and fully compliant with global mandates. This is critical for Life Sciences, Pharmaceuticals, Medical Device, other advanced manufacturers to mitigate risk and avoid costly penalties. With eLeaP’s validated QMS, you can have total confidence that your quality data is reliable, secure, and ready for any regulatory inspection including 21 CFR Part 11 and 14 CFR compliance.
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Avoid Penalties and Maintain Compliance
The eLeaP QMS provides a secure, Multi-Factor Authentication environment for managing electronic records. Ensure your business meets all regulatory obligations while mitigating the risk of costly non-compliance penalties.
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Manage Electronic Records and Signatures
Ensure all electronic signatures are reliable, traceable, and fully trustworthy. This provides a critical layer of security for heavily regulated industries, preventing unauthorized changes to vital quality data.
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Ensure Authenticity and Record Integrity
Streamline your quality processes while significantly reducing the risk of manual errors. Demonstrate uncompromising compliance with industry standards to gain a competitive advantage in the market.
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Total Peace of Mind and Audit Confidence
Our validated system ensures you meet strict compliance obligations with ease. Gain full confidence in the reliability of your electronic records, knowing they are backed by a robust, audit-ready infrastructure.
See what our clients say about us
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Thank you for all your help. I’m really pleased with how easy it is to set up courses, upload content and assign users in eLeaP.
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The eLeaP system is very user-friendly, and it significantly improved our current process. The thing that was most impressive to me was the customer service. It’s very rare that a CEO would take the time to sit with a client and help them with their every need.
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Wow! Thank you so much. Your eLeaP service has been amazing.