Unique Device Identification Enhancements
PTC Windchill 10.2 M010 contains several enhancements to Unique Device Identification (UDI) functionality.
|Product / Module||
PTC Windchill QMS
PTC Windchill UDI
|Product Functional Area||
|User Interface Location|
|Processes, Initiatives, and Best Practices||
Quality and Reliability Management
Benefits and Description
The following features have been added to the Unique Device Identification (UDI) module. Many of these features focus on handling multiple UDI submissions at the same time.
- Validate and approve multiple submissions: Many customers have product lines with similar products. This new process allows users to validate several UDI submissions at once. After the submissions have been validated, users can approve multiple submissions at the same time.
- Handle all submissions that have been delayed by the FDA: Occasionally, the FDA Electronic Submission gateway stops processing UDI submissions due to system downtime. This new process allows users to process several delayed submissions at once, rather than one at a time.
- Update multiple submissions when source data changes: UDI submissions combine data from many sources. When the source data in an existing UDI submission has changed, the UDI must be resubmitted to the regulatory agency. This new process allows users to resubmit their updated UDI information for multiple submissions.
- Handle table data in spreadsheets more efficiently: Excel spreadsheet import functionality of UDI submission data allows sample sheets for object types with a 1:many relationship. This functionality supports UDI submissions that have the same name but a different type.
- View reports from History tables: The icon to view reports is in a new column next to the information page icon in the History tables for eMDR and UDI. This icon allows users to view eMDR and UDI reports without having to navigate to additional pages. This behavior is consistent with other quality items.
For more information, see the "Unique Device Identification" topic collection in the PTC Windchill Help Center. Tip: Enter the topic name in the PTC Windchill Help Center search field to easily navigate to the topic.