Opvia Logo
Opvia Logo

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.

See GxP OS

  • Identify your pain points
  • Understand your requirements
  • Design and build your ideal system with:
  • quotation marks
    Tom Owen
    Solutions Lead at Opvia
  • Join startups and Fortune 500s on the Opvia platform:
  • revyve
    valitacell logo transp
    clonakilty distillery unsmushed
    bioventix
    bvc logo horz
    ingenza
    nexterra logo
    mialgae logo
    beckman coulter

    * We prioritize your privacy. Rest assured, the data submitted via this form will remain confidential. This is in strict adherence to our privacy policy.