Healthcare UDI
HEALTHCARE
Leading Global Healthcare Device Manufacturer
Automated regulatory compliant healthcare device identification.
Objectives
The client required a centralized system to manage Unique Device Identification (UDI) data for their globally regulated medical devices. Manual processes created risks in regulatory compliance, data inconsistencies, and operational inefficiencies. The objective was to develop a web-based platform to automate UDI creation, validation, and lifecycle management. The system needed to ensure compliance readiness, improve accuracy, and support bulk operations across multiple plants.
Solutions
We developed a secure web-based UDI management platform enabling users to create, view, edit, and manage device identification records through an intuitive interface. The system centralized UDI data management across multiple manufacturing plants and ensured consistency through integration with master data systems. Structured approval workflows were implemented to ensure regulatory compliance and audit readiness. Bulk import capabilities allowed large datasets to be uploaded, validated, and processed efficiently with automated error detection. Validation rules ensured high data accuracy before approval and publishing. Role-based access controls ensured secure and compliant operations. The system also maintained complete audit trails for traceability and regulatory inspections. Dashboards and reporting features provided operational visibility and compliance monitoring.
Benefits
- Reduced manual UDI processing effort by 70% improving operational efficiency
- Improved data accuracy to 99% ensuring regulatory compliance reliability
- Accelerated UDI bulk upload processing by 5x across facilities
- Strengthened compliance readiness with complete audit traceability
- UDI MANAGEMENT SYSTEM
- REGULATORY COMPLIANCE AUTOMATION
- MASTER DATA INTEGRATION