Uploads up to 5000 UDIs in one batch. All of the UDIs uploaded will be validated against FDA rules and will give user friendly errors to help with the data cleansing process. It can also be used as a UDI migration tool.
2. Rule Engine Admin Client:
The rule engine is a flexible web interface to configure FDA validation rules. Business users will be able to create/modify FDA rules and it will not require source code change or recompilation
3. Agile PLM:
The UDI solution is tightly coupled with Agile PLM and it uses its revision and workflow management:
Pre-configured templates for UDI
Workflow to implement UDI process – creation, review and released steps
Approval Matrix implementation for UDI related functional teams
Revision Management and Finished good association. The UDI document will be created as the bill of material component of a Finished good
Process Extensions to create HL7 standard to be submitted to ESG gateway
ACS configurations to export UDI data
Direct UDI submission to FDA from Agile PLM
This is Xavor proprietary middleware that will help to extract data from different systems such as PLM, ERP, Regulatory, Labeling Software etc. The Process extension that will create HL7 XML file uses xEngine to extract and transform the UDI data. The xEngine will also be used to submit the file to ESG gateway using AS2 servers.
For more information about Xavor’s solution offerings and implementation best practices:
As Xavor’s Managing Consultant, Hassan Sheikh has over 14 years of experience working with Oracle Agile PLM. He has extensively worked with large enterprise companies within the semiconductor, high-tech and medical device verticals.