Siebel Life Sciences Guide > Regulatory Reporting >

Process of Regulatory Reporting

This example process represents the tasks that are carried out in the Scenario for Regulatory Reporting.

Administrator Procedures

• Setting Up Report Numbers

End-User Procedures

1. Creating and Populating New Regulatory Reports
2. Entering and Reviewing Data for 3500A Reports, or
3. Entering and Reviewing Data for MDV Reports
4. Running 3500A and MDV Reports
5. Generating Regulatory Report Numbers and Submitting Reports
6. Transmitting Electronic Medical Device Reporting Immediately
7. Managing Batch Electronic Medical Device Reporting
8. Reopening a Regulatory Report
9. Creating Supplemental or Follow-Up Regulatory Reports

Additional End-User Procedure

This end-user procedure is not part of the scenario described:

• Reopening a Regulatory Report