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Device History Records

Opvia for Device History Records: Comprehensive Documentation and Integration

An electronic device history record (eDHR) allows device companies to centrally collect and maintain all of the records required by the FDA's Quality System Regulation (21 CFR Part 820) to document the production of each batch, unit or lot of a finished device. The Opvia platform offers robust capabilities for managing Device History Records (DHR), providing organizations with a comprehensive solution to document and track the manufacturing history of medical devices. Built to exact needs and integrated within the same platform, Opvia seamlessly integrates with Quality Management Systems (QMS), quality data management, and batch record capabilities, ensuring efficient and compliant manufacturing processes.

Device History Records Specification Sheet: Opvia Platform
Device History Records Specification Sheet: Opvia Platform
Device History Records Specification Sheet: Opvia Platform

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