Setting Up a Local AS2 Gateway to Test Your Data
Configure your quality solution and AS2 gateway with the FDA registration results and digital certificate.
1. Implement an AS2 server to perform the submission to the FDA AS2 gateway and to process the acknowledgements.
2. Optionally, in Windchill, change the file drop location. The Unique Device Identification module uses file drop functionality to create the HL7 message to be processed by the AS2 server and sent to the gateway. Acknowledgements returned to the AS2 server must be written to files to be picked up by the file drop function.
The default folder configuration is in the Windchill temp directory $(wt.temp) in filedropfdacommunications\<location>, where <location> is out, in, or orphan.
If a change is needed to this path, update the QMS.fdacommunicationfiledrop.properties.xconf file. This configuration file has five entries:
a. An outbox location for outgoing HL7 messages.
b. An inbox location of incoming acknowledgements from the FDA.
c. An orphan location for incoming acknowledgements from the FDA that cannot be linked to a previous communication.
d. A targz location. The files for UDI submissions are packaged in a tar.gz format.
e. A fileDropWaitTime entry. This property is the wait time to check the files in the directories for processing.
3. Test your UDI submission data. Any type of data can be submitted for your testing because the data is loaded only in the test database.