Siebel Life Sciences Guide > Regulatory Reporting > Process of Regulatory Reporting >

Generating Regulatory Report Numbers and Submitting Reports

When you generate a 3500A or MDV initial report:

• The report number is generated and filled in
• The Status field changes to Submitted
• The fields in the regulatory report record become read-only (except for the Sub Status field)

Only the primary owner of the regulatory report can generate the report number and submit the report.

This task is a step in Process of Regulatory Reporting.

To generate and submit a regulatory report

1. Make sure the application is running on a server database.

   You cannot generate a report number on the Siebel Mobile Web Client.

2. Navigate to Regulatory Reports screen, then the My Regulatory Reports view.
3. In the Regulatory Report List, drill down on a regulatory report with status of In Progress.
4. Click Generate.

   This starts the LS Medical Product Issue RR Submit workflow, which authenticates the user, adds a number for the regulatory report, changes the status to Submitted, and makes all fields except Sub Status read-only.

   For more information about the workflow, see LS Medical Product Issue RR Submit Workflow.

5. To submit the regulatory report to the FDA, click eMDR Queue.

   This changes the Sub Status of the report to eMDR and places the report in the queue to be sent to the FDA at the end of the month. If you want to submit the report immediately, follow the instructions outlined in Transmitting Electronic Medical Device Reporting Immediately.