Reports submitted in old format and subsequently in XML outside Oracle Argus

If you have legacy PMDA Device cases submitted in the old format of Form 8 or Form 10, and subsequent follow-ups have been submitted in XML format using the PMDA free tool, follow the following steps to submit subsequent follow-up device reports once you upgrade to Oracle Argus 8.4:

1. Unlock the case to enter the follow-up information.
2. Update all the data in the case as per the device XML submitted to PMDA using the free tool outside Oracle Argus. This step is required to synchronize up the same data in the case maintained in Oracle Argus.
3. Save and lock the case.
   The PMDA device Form 8 XML initial report is scheduled and generated with the same data as the one generated outside Oracle Argus.
4. Transmit and mark the initial report as submitted. Ensure that the physical XML file is not transmitted to the PMDA gateway.
5. Verify that the M.2.5.1 report count tag in the report is set to 1.
6. Import the acknowledgment file obtained from PMDA.

   Note:

   Before importing the acknowledgment, remember to update the MESSAGENUMBER to match the Device XML generated in Oracle Argus.
7. After the acknowledgment is imported, verify that the PMDA control number is populated with the year and reference number in the PMDA Management Number section on the Product tab.