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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.

This task is a step in Process of Regulatory Reporting.

CAUTION:  Regulatory report records cannot be deleted.

To create a regulatory report record

1. Navigate to Product Issues screen, then the Product Issue List view.
2. Drill down on a product issue.
3. Click the Regulatory Reports view tab.
4. In the Regulatory Reports list, create a record.

   When the regulatory report is created:

   • These fields are copied from the product issue: PI# and SR #
   • These fields are set with a default value: Status = In Progress, Owner = Creator of the record
5. 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.