Quality Management System
Streamlined Quality & Compliance for Regulated Industries
eLeaP eQMS: Your Complete Quality Management Solution
Elevating Quality for Regulated Industries
In regulated industries, compliance and quality are the foundation of success. The eLeaP eQMS (Electronic Quality Management System) streamlines and enhances your quality management processes, ensuring your organization is always audit-ready, compliant, and efficient.
Core Modules in eLeaP eQMS
The eLeaP eQMS is built around powerful, interconnected modules designed to simplify your quality processes, ensure compliance, and drive efficiency. From managing critical documents to mitigating risks, our system provides all the tools you need to stay audit-ready and operationally effective. Explore our core modules below.
-
Document Management
Simplify the management of critical documents with centralized storage, automated version control, and seamless workflows for review and approval. Ensure your team always works with the most up-to-date information.
-
Design Control
Ensure compliance with regulatory standards through robust management of [User Needs], [Design Inputs], [Design Outputs], [Design Verifications], and [Design Validations]. Perfect for medical device and product development teams.
-
Risk Control
Manage hazards and minimize potential risks through tools that identify, evaluate, and control threats to product quality and safety. Stay proactive and compliant.
-
Risk Management
Go beyond controlling risks by implementing a systematic process to assess and mitigate risks across all stages of your operations. This module aligns with industry best practices for risk-based decision-making.
-
Events for CAPAs and Investigations
Handle Corrective and Preventive Actions (CAPAs), non-conformance investigations, and other quality events with ease. Use automated workflows to ensure proper tracking, reporting, and resolution of issues.
-
Learning Management Integration
Integrated with the eLeaP LMS, this module ensures your team stays trained and compliant with updated SOPs, certifications, and regulatory requirements. Simplify onboarding and continuous learning.
-
Supplier Management (Coming Soon)
Maintain control over supplier qualifications, audits, and performance. Build stronger relationships and ensure supplier compliance with this upcoming module.
Why eLeaP eQMS?
- Comprehensive & Scalable: A modular system that grows with your needs.
- Built for Regulated Industries: Align with standards like FDA 21 CFR Part 11, ISO 13485, and GMP.
- Streamlined Processes: Eliminate inefficiencies with automated workflows and centralized data.
- Audit-Ready: Maintain complete records for inspections and audits.
- Secure Cloud-Based Platform: Protect your data with advanced security features and ensure accessibility for authorized users.
Designed for Regulated Industries
The eLeaP eQMS is tailored for industries where quality and compliance are critical:
- Life Sciences and Medical Devices: Meet ISO 13485 and FDA requirements effortlessly.
- Pharmaceuticals: Stay compliant with GMP and other global regulatory standards.
- Manufacturing: Optimize processes and maintain quality with comprehensive risk management tools.
Experience the Power of eLeaP eQMS
The eLeaP eQMS isn’t just software—it’s your partner in quality management. Whether managing documents, addressing CAPAs, or ensuring supplier compliance, our platform delivers the tools you need to achieve operational excellence.