1 Introduction

1.1 General Installation and Software Requirements

This section contains table that show the software installation requirements for small, mid-sized, and large companies for the following:

• Argus Safety Database Server

  
  

  Note: Argus Safety 8.1 both Standard and Enterprise Editions support the CDB/PDB as well as Non-CDB database formats of the Oracle Database 12.1.0.2.

  
  

• Argus Safety Web Server

  
  

  Note: The ArgusSecureKey.ini file should be placed under the .\Windows folder. Refer to the Generating a New Cryptography Key section to create a cryptography key. Report Server is not required for the Argus Safety installation. Existing customers can convert the Report Server to an Argus Web Server. Refer to the Converting Argus Safety Report Server to Argus Web Server section for details.

  
  

• Argus Transaction Server

  
  

  Note: We do not recommend that AG/ESM Service runs on the Web Server, because the agproc.exe and argusvr2.exe services might conflict with each other when running together.

  
  

• Argus Interchange Server

  The Argus Interchange Server is an optional component meant to off-load Interchange Service from the Argus Transaction Server. Alternatively, Interchange Service can be installed on the Transaction Server itself.

• Argus Safety Web Client

• Argus End of Study Unblinding Tool

• Argus Safety OBIEE/BI Publisher Server

  The OBIEE/BIP Server installation is optional, and required only if Argus Safety Flexible Aggregate Reporting (FAR) through BI Publisher is enabled.

  Argus 8.1 supports OBIEE/BI Publisher 12.2.1.

  Refer to the OBIEE 12c Installation Guide for Hardware and Software requirements.

See Hardware Requirements for Argus Safety for hardware requirements.

1.2 Pre-Requisite Installation Order

When installing the pre-requisites for the servers, the following order should be followed for installing each component. Depending on the server being installed, some of the pre-requisites may not be needed and can be skipped. After these are installed, you can install the rest of the pre-requisites (if any are needed) in any order prior to installing Argus.

• Windows Operating System

• Internet Information Services

• Microsoft .NET Framework

• Oracle Client 12.1.0.2 (32-bit)

• Oracle ODP.NET

  
  

  Note: If you install Windows and run Windows Updates without installing IIS first, Microsoft.NET will be installed first without correctly setting up ASP.NET. In the event this occurs where IIS is installed after Microsoft .NET, refer to Microsoft Support on how to re-register ASP.NET in IIS. This is usually accomplished by running aspnet_regiis.exe -i from the.NET V2.0.50727 folder. 1) Manually modify Machine.config Path: ”%windir%\Microsoft.NET\Framework\v2.0.50727\CONFIG To modify the default .NET Transaction Scope time, the following change should be made in the configuration file: </system.serviceModel> <system.transactions> <machineSettings maxTimeout="01:00:00" /> </system.transactions> </configuration> The value specified in maxTimeout is applicable for all Argus servers.

  
  

1.3 Argus Safety Hardware Topology

This section provides information about the recommended hardware topology and hardware requirements for small, mid-size, and large companies.

The size of your company and licensed Argus components determines the distribution of the software among the servers.

The following are the definitions for small, mid-sized, and large companies.

Small Company: A small company is a company that has from 1 to 50 concurrent users and fewer than 200 new cases reported each month.

Mid-Sized Company: A mid-sized company is a company with 51 to 100 concurrent users and 300 to 600 new cases reported each month.

Large Company: A large company is a company with more than 100 concurrent users and approximately 1000 to 5000 new cases reported each month.

1.3.1 Recommended Hardware Topology for a Small Company

The following image shows the recommended hardware topology for the Argus Safety Hardware for a small company.

1.3.2 Recommended Hardware Topology for a Mid-sized Company

The following image shows the recommended topology for the Argus Safety Hardware for a mid-sized company.

1.3.3 Recommended Hardware Topology for a Large Company

The following is an illustration of the recommended topology for a large company.

1.4 General Pre-Installation Tasks

Before installing the Argus Safety software, be sure to do the following:

• Set the resolution for the client workstation to a minimum of 1280 X 1024 for optimum viewing of the application. If the screen resolution is less than 1280 X 1024, some of the field labels may appear truncated.

• Make sure that the regional settings on the web server are American settings.

• Install East Asian languages on the following:

  • Argus Web Server

  • Argus Service Server

  • Interchange Transaction Server

  • Argus Web client machines

  • Install the Japanese font pack for Adobe Reader on the Argus Web client machines. If you fail to install this font pack, you will be unable to view the Japanese data correctly.

1.5 Installation Process Overview

The following is the recommended order for installing the Argus Safety solution components:

1. Install the Schema Creation Tool

2. Create/Upgrade Argus Safety Database Schema

3. Load the Factory Data

4. Execute the Argus Safety Database Schema Validation

5. Install the Argus Safety Web Component

6. Load MedDRA

7. Load WHO-Drug

8. Load J Drug (if you are using Argus J)

9. Install the Argus Safety Services / Interchange Service / Interchange Mapping

10. Configure the Argus Safety Service

11. Configure the Interchange Service

12. Install and Configure Axway Synchrony

13. Maintain Installation

1.6 Converting Argus Safety Report Server to Argus Web Server

Execute the following steps to convert Argus Safety Report Server to Argus Web Server:

1. Navigate to the Argus Safety Report Server.

2. Go to C:\Windows and open the argus.ini file.

3. Delete references to the ReportServerUser, ReportServerPassword and ReportServerPriority.

4. Update the entry for ReportServer to HTTP://Localhost