Informatica UDI Compliance Accelerator
Posted by: Informatica Master Data Management
Informatica UDI Compliance Accelerator is an Informatica MDM MDE based accelerator configuration that has a multi-domain data model and business rules configured for master data management related to UDI (Unique Device Identification), Medical Devices, and Labeler Information. It also has a UDI Compliance Workflows built into achieve compliance with UDI ruling.
The Informatica UDI Compliance Accelerator helps Medical Devices manufacturers to comply with the FDA UDI ruling. [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm]Using the solution, you can perform the following tasks:
- Generate a UDI for a medical device or package of medical devices that falls within the range of UDI serial numbers owned by the labeler
- Create a device identifier record and product identifier record for each medical device by extracting the required information from internal and external systems
- Merge and cleanse data
- Enrich the records with optional data
- Manage an internal review-and-approval business process for UDI records
- Publish the record in a format supported by the UDI ruling
FeaturesData model covering all attributes guided by FDA for UDI submission.Additional entities covering device information, labeler information and submission workflow status.Vapdation rules per FDA GUDID submission norms.Out-of-the-Box business user interface (Informatica Data Director) to create/modify/submit DI Record. Informatica BPM workflow for approval of new/modified DI record and Unique ID Assignment.Multiple roles for workflow.Informatica DI Mappings for consuming inbound data.Informatica DI Mappings for creating GUDID Pubpsh Datasets.
Informatica UDI Compliance Accelerator asset includes:
- Multi-domain Medical Devices data model based on Informatica IP.
- One pre-configured MDM ORS.
- One IDD configuration.
- Dashboard for IDD.
- Informatica DI mappings to consume data and publish records to FDA.
- ActiveVOS based workflow to create, modify, assign and submit UDI information to FDA.
- Design documentation supporting the configuration.