Xavor has designed a flexible UDI solution using Agile PLM that helps to minimize data management challenges while implementing UDI regulation.
The solution consists of three major components:
1. UDI Wizard:
It is a web application which captures UDI data from the business users. It supports the following functionalities:
- Captures UDI data from business users and inserts into Agile PLM as a document. The application also helps the UDI document to be associated to its Finished good part number
- Validates data UDI against the FDA rules
- 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.