Siebel Life Sciences Guide > Regulatory Reporting >

Generating Regulatory Report Numbers and Submitting Reports (End User)

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 > My Regulatory Reports view.
3. 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.