1 Empirica Signal Overview

This chapter includes the following sections:

• Introduction to the Empirica Signal software

• Assumptions

• Physical configuration options

• Components of the installation package

Introduction to the Empirica Signal software

The Empirica Signal software is a web-based analysis environment for generating statistical scores for combinations of drugs and events in a drug safety database, and for detecting signals (unexpected associations of drugs and events).

Assumptions

This guide assumes familiarity with the following activities:

• Setting Linux file permissions.

• Administering WebLogic.

• Configuring Linux services.

• Setting up and configuring the Oracle Database.

Physical configuration options

The Empirica Signal software is typically installed in a two-tier configuration, using separate database server and application server machines. The provisioning and basic setup of the two systems is outside the scope of this document.

Components of the installation package

The installation package contains the following components.

File	Description
Signal_Install.tar.gz	Components for installing the Empirica Signal software.
Signal-8_0_1_0_XXX.zip	Build that you install, where XXX is the build number.
Database.zip	Scripts for setting up the Empirica Signal database account.
IQ_Test.doc	Document for installation qualification information.
OQ_Test.doc	Document for operational qualification information.
UQ_Test.doc	Document for upgrade qualification information.

Note: If you plan to document your installation or upgrade with the provided IQ_Test.doc or UQ_TEST.doc, familiarize yourself with the contents of the corresponding document and fill it in as you proceed through the instructions in this document.