e-DMR
Device Master Record Management System
overview
e-DMR is a next-generation Device Master Record (DMR) management system engineered to support regulatory compliance, product quality, and manufacturing consistency. Designed for industries such as medical devices, electronics, and aerospace, e-DMR ensures that every product’s design, manufacturing, and inspection requirements are documented, maintained, and easily accessible. With built-in AI capabilities, e-DMR automates key processes, reduces manual overhead, and provides complete control over master documentation throughout the product lifecycle.
Key Features:
- Regulatory Forms Supported
e-DMR supports all necessary documentation formats required by global regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485). It enables structured creation and management of specifications, drawings, BOMs, routing instructions, quality procedures, and packaging requirements.
- Automated Workflow and Approvals
Define and enforce approval workflows for the creation and revision of DMR content. e-DMR automates routing to relevant stakeholders, sends reminders, and ensures all changes are reviewed and signed off before release.
- Automated Form Filling and Submission
Using AI, e-DMR pulls data from integrated design, ERP, or PLM systems to automatically generate and populate key documents. This minimizes manual data entry, reduces errors, and accelerates the document preparation process.
- Centralized Document Management
All DMR-related documents are stored in a centralized, secure repository. The system maintains full version control, audit trails, and structured categorization, ensuring fast access and traceability for audits or design changes.
- Scalability and Flexibility
Whether you’re managing a single product line or a global portfolio of complex assemblies, e-DMR scales effortlessly. The system is modular, allowing you to configure it according to organizational size, industry requirements, and workflow complexity.
- Secure Data Management
Ensure the integrity and confidentiality of your master records with robust security protocols, role-based access controls, and compliance with data protection standards. e-DMR guarantees your sensitive product data is protected.
- Reporting and Analytics
Leverage built-in analytics to monitor documentation health, track revision history, and measure workflow performance. AI-driven dashboards provide real-time insights into document status, approval cycles, and compliance metrics.
- Integrations with Enterprise Systems
e-DMR integrates seamlessly with PLM, ERP, CAD, QMS, and MES systems, ensuring consistent data flow across product development and manufacturing ecosystems. This reduces redundancy and improves overall process efficiency.
- Integrated Compliance Tracking
Track compliance across the product lifecycle with audit-ready documentation and real-time alerts. e-DMR ensures all product definitions and changes are fully traceable and aligned with regulatory and quality requirements.
Benefits of e-DMR:
- Maintains complete and compliant master documentation for every product.
- Automates approval and revision workflows for greater speed and control.
- Centralizes document storage and ensures traceability.
- Reduces human error through AI-assisted data population and integrations.
- Scales with your organization and adapts to changing regulatory demands.
- Enhances audit readiness with full compliance tracking and reporting.
Conclusion:
e-DMR empowers engineering, quality, and regulatory teams to manage Device Master Records with precision and confidence. By digitizing and automating DMR processes, it helps organizations ensure manufacturing consistency, regulatory compliance, and product excellence from concept to production.
