Oracle has partnered with Inspirage to support the UDI initiative and enable Medical Device customers to meet the imposed sunrise date.

Oracle-UDI-Solution-Architecture-1

The Inspirage and Oracle UDI Solution Overview

  • Captures and manages all Device Identifier (DI) attributes
  • Enables revision control access to this data and a workflow to support the initial release, publishing (for submittal) and update process
  • Manages the UDIs within the Device Medical Record (if maintained in Agile)
  • Manages the UDIs as a child of the Finished Good (if no DMR exists)
  • Dynamically creates GTINs from the UDI data for each package variation of the Finished Good
  • Leverages the UDI and product attribution data set to generate and store this data
  • Creates master with Reference DHFs for Country-Specific Product Registration
  • Provides specific configuration that creates a GTIN to a country’s product registration
  • Enables an automated submittal to the FDA’s eSubmittal Gateway leveraging the HL7 SPL format upon release of the UDI object within the workflow at the proper lifecycle
  • Leverages ACS as well as a custom servlet to manage the communication portion from the customer to the FDA
  • Can also be configured to manage both the Submittal, Publish and Update activities
  • Can also be configured to just output the formatted data and not perform the submittal to the FDA Gateway
  • Enable an extract to be sent to the Supply Chain/Manufacturing system for consumption onto the UDI label itself upon release of the UDI object within the workflow at the proper lifecycle1

1 This can be sent to a system like PIM, EBS, JDE, SAP or to a partner’s system.

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