Quality Manager

It is the quality manager’s responsibility to prepare the initial MedWatch 3500A form and send it to the FDA. First, she creates a new regulatory report record and populates the record with data from the product issue. Then she reviews the data.

Because her company manufactures the cartridge, she enters data into the Manufacturer and Investigation views. This data will appear in sections G and H of the MedWatch 3500A form.

Satisfied that the necessary data has been entered, she generates the MedWatch 3500A report. This report is a facsimile of the MedWatch 3500A form. But, it is also a standard Siebel report, so the quality manager prints it as she would any other Siebel report.

After reviewing the printed version of the report, she submits it. When she submits the report record, two things happen:

• A report number is generated.

• Most fields in the report record become read-only.

It is the submitted version of the MedWatch 3500A form that the quality manager sends to the FDA.

The quality manager complied with regulations by sending her initial report within 30 days of the company becoming aware of the issue. However, the product analysis had not been completed at that time. Later, the product analysis team discovers the root cause of the cartridge failure, and the quality manager submits a supplemental report to the FDA.