Running 3500A and MDV Reports

Siebel AECM uses the Siebel Reports Server to create formatted reports suitable for submitting to the FDA or other regulatory agency.

Typically, the user views the report:

• Before generating it, to make sure that the data is correct

• After generating it, to print a final report for sending to the FDA or other regulatory agencies

Note: The fields used to fill in the report are those in the regulatory report record (not the product issue record).

This task is a step in Process of Regulatory Reporting.

To run a report

1. Navigate to the Regulatory Reports screen, then the Regulatory Report List view.

2. In the Regulatory Report List, drill down on a report.

   For this type of report...	Navigate to one of these views...	Select this report from the Reports button menu
   MedWatch 3500A	More Info Patient Importer Manufacturer Investigation	3500A
   MVD	More Info Patient MDV	MDV

3. Run, print, and save the report as necessary. For information about reports, see Siebel Fundamentals.