Siebel Life Sciences Guide > Regulatory Reporting >

Scenario for Regulatory Reporting

This scenario is an example process performed by the Siebel administrator and the quality manager. Your company may follow a different process according to its business requirements.

This scenario is designed to illustrate the functionality of Siebel AECM.

Introduction

A complaint about a cartridge for a blood analyzer machine has been made to the manufacturer. The complaint has been assessed; it needs to be reported to the FDA. A product issue record has already been set up and contains a lot of information about the complaint.

The Siebel Administrator

The administrator is responsible for setting up the report number schema for the organization. The company started using Siebel AECM in the middle of the year. Because the company had already submitted eight MedWatch 3500A reports to the FDA, the administrator sets the report number sequence to start at 9.

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.