Reopening a Regulatory Report

If you want to make a change in a generated (submitted) regulatory report record, you need to reopen it. Only the primary owner of the regulatory report can reopen it.

When you reopen a report:

• The Status field changes to Reopen

• The fields in the regulatory report record can be edited

This task is a step in Process of Regulatory Reporting.

To reopen a regulatory report

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

2. In the Regulatory Report List, drill down on a regulatory report with status of Submitted.

3. Click Reopen.

   This starts the LS Medical Product Issue RR Reopen workflow, which authenticates the user and changes the status of the report to Reopen.

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