Creating and Populating New Regulatory Reports

The best way to create a regulatory report record is from the product issue record. When a report is created from the regulatory report, fields (for example, products) can be populated from the product issue record to the regulatory report record.

There are two kinds of initial regulatory report that you can create:

• MedWatch 3500A

• MDV Initial

Note: If you want to create supplemental or follow-up reports, see Creating Supplemental or Follow-Up Regulatory Reports.

Caution: Regulatory report records cannot be deleted.

This task is a step in Process of Regulatory Reporting.

To create a regulatory report record

1. Navigate to Product Issues screen, then the Product Issue List view.

2. In the Product Issue List, drill down on a product issue.

3. Click the Regulatory Reports tab.

4. In the Regulatory Reports list, create a new record and complete the necessary fields.

   When a regulatory report is created:

   • The following fields are copied from the product issue: PI# and SR #

   • The following fields are set with a default value: Status is set to In Progress, Owner is set to Creator of the record

5. For the new record, set the Report Type field to MedWatch 3500A or MDV Initial.

6. Click Populate Report.

   This starts the LS Medical Product Issue Populate Report workflow, which copies data from the product issue according to the report type. For more information about the workflow, see LS Medical Product Issue Populate Report Workflow.