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Oracle® Argus Safety Installation Guide Release 7.0.1 E26221-02 |
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# 1 Introduction

This section includes the following information:

- General Installation and Software Requirements

- Pre-Requisite Installation Order

- Argus Safety Hardware Topology

- General Pre-Installation Tasks

- Installation Process Overview

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.

## General Installation and Software Requirements

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

- Argus Safety Database Server

- Argus Safety Web Server

- Argus Safety Report Server

- Argus Transaction Server

- Argus Safety Web Client

- Argus Safety Dossier Web Client

- Argus Interchange Transaction Server

## 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

- 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, please 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.

### Argus Safety Database Server Installation Requirements

The following table describes Argus Safety Database Server Configuration.

# | Argus Safety Database Server Configuration | Small | Mid-Sized | Large | Very Large
--- | --- | --- | --- | --- | ---
1 | RAM | 4 -- 8 GB | 8 - 16 GB | 16 - 32 GB | 16 - 32 GB
2 | CPU | Equivalent to 2 - 4 Dual Core, 3GHz | Equivalent to 4 - 8 Dual Core, 3GHz | Equivalent to 16 Dual Core, 3GHz | Equivalent to 16 Dual Core, 3GHz
3 | SOFTWARE | 11.2.0.1 Server (Standard/Enterprise) - AL32UTF8 character set 11.2.0.3 Server (Standard/Enterprise) - AL32UTF8 character set Windows 2008 SP2 Standard/Enterprise (32-bit) Windows 2008 R2 Standard/Enterprise (64-bit) (English version for all above OS) | 11.2.0.1 Server (Standard/Enterprise) - AL32UTF8 character set 11.2.0.3 Server (Standard/Enterprise) - AL32UTF8 character set Windows 2008 SP2 Standard/Enterprise (32-bit) Windows 2008 R2 Standard/Enterprise (64-bit) (English version for all above OS) | 11.2.0.1 Server (Standard/Enterprise) - AL32UTF8 character set 11.2.0.3 Server (Standard/Enterprise) - AL32UTF8 character set Windows 2008 SP2 Standard/Enterprise (32-bit) Windows 2008 R2 Standard/Enterprise (64-bit) (English version for all above OS) | 11.2.0.1 Server (Standard/Enterprise) - AL32UTF8 character set 11.2.0.3 Server (Standard/Enterprise) - AL32UTF8 character set Windows 2008 SP2 Standard/Enterprise (32-bit) Windows 2008 R2 Standard/Enterprise (64-bit) (English version for all above OS)

#### Oracle Considerations

The system is certified for the following Oracle Standard/Enterprise versions (English version is used for all the Operating Systems listed below):

- Linux - Oracle Enterprise Linux X86/86-64 (Version 5.5.0.0.0/5.7.0.0/6.1 UEK)

- Sun - Solaris 10

- Virtualization - Oracle Virtual Machine - OVM 2.2.1/2.2.2

### Argus Safety Web Server Installation Requirements

The following table lists the hardware and software installation requirements for the Argus Safety Web Server.

Requirement Type | Requirement Description | Small | Mid-Sized | Large
--- | --- | --- | --- | ---
Software | Windows 2008 SP2 Standard/Enterprise (32-bit) Windows 2008 R2 Standard/Enterprise (64-bit) (English version for all above OS) | X X | X X | X X
| Oracle Standard/Enterprise, Version 11.2.0.1/ 11.2.0.3 (11.2.0.1/ 11.2.0.3 Client, 32-bit only) | X | X | X
| Oracle 11.2.0.1/ 11.2.0.3 OLE Objects / Oracle ODP.net 11.2.0.1/ 11.2.0.3 | X | X | X
| Oracle ODAC 11.2.0.1/ 11.2.0.3 | X | X | X
| Oracle Access Manager 10gR3 (10.1.4.3) | X | X | X
| WebGate 10.1.4.3 (Optional installation for SSO Integration with Oracle Access Manager 10.1.4.3) | X | X | X
| LDAP/LDAPS 3.0 (Optional) | X | X | X
| Adobe Acrobat Reader, Version 9.3.4 | X | X | X
| Microsoft Internet Explorer, Version 8.0/9.0 | X | X | X
| Microsoft Word 2007 (32 bit) Microsoft Word 2010 (32 bit) (Microsoft Word is required only if the Argus Dossier module is to be used) | X | X | X
| IIS, Version 7.0 IIS Version 7.5 (Windows 2008 R2 on 64-bit) | X | X | X
| E-mail Support SMTP |  |  |
| Microsoft XML Parser 6.0 | X | X | X
| Visual C++ 2008 SP1 Runtime | X | X | X
| Microsoft .NET 3.5 Framework | X | X | X
| Documentum DFC, Version 6.5 SP2/SP3 (Optional. Installed only when Documentum is used) * | X | X | X
| WebCenter 11.1.1.4 (on WebLogic 10.3.4). This component is optional and is required only for Multi-tenant installations to deploy global homepage and its portlets. | X | X | X
Hardware | 1 CPU X 3 GHz, 4 GB Memory/CPU | X | X | X
| 2 CPUs X 3 GHz, 4 GB Memory/CPU |  |  | X
| Physical Server or Oracle Virtual Machine 2.2.1/2.2.2 | X | X | X
| Minimum Resolution 1280X1024 | X | X | X

### Argus Safety Report Server Installation Requirements

The following table lists the hardware and software installation requirements for the Argus Safety Report Server.

Note: The Web Server and the Report Server can be installed on a single instance of the Windows meeting the following requirements.

Requirement Type | Requirement Description | Small | Mid-Sized | Large
--- | --- | --- | --- | ---
Software | Windows 2008 SP2 Standard/Enterprise (32-bit) Windows 2008 R2 Standard/Enterprise (64-bit) (English version for all above OS) | X X | X X | X X
| Oracle Standard/Enterprise, Version 11.2.0.1/ 11.2.0.3 (11.2.0.1/ 11.2.0.3 Client, 32-bit only) | X | X | X
| Oracle 11.2.0.1/ 11.2.0.3 OLE Objects / Oracle ODP.net 11.2.0.1/ 11.2.0.3 | X | X | X
| Oracle ODAC 11.2.0.1/ 11.2.0.3 | X | X | X
| Adobe Acrobat Reader, Version 9.3.4 | X | X | X
| Microsoft Word 2007 (32 bit) Microsoft Word 2010 (32 bit) (Microsoft Word is required only if the Argus Dossier module is to be used) | X | X | X
| Microsoft Internet Explorer, Version 8.0/9.0 | X | X | X
| IIS, Version 7.0 IIS Version 7.5 (Windows 2008 R2 on 64-bit) | X | X | X
| Microsoft XML Parser 6.0 | X | X | X
| Visual C++ 2008 SP1 Runtime | X | X | X
| Microsoft .NET 3.5 Framework | X | X | X
| Documentum DFC, Version 6.5 SP2/SP3 (Optional. Installed only when Documentum is used) * | X | X | X
Hardware | 1 CPU X 3 GHz, 4GB Memory/CPU | X | X |
| 2 CPUs X 3 GHz, 4 GB Memory/CPU |  |  | X
| Physical Server or Oracle Virtual Server 2.2.1 / 2.2.2 | X | X | X

### Argus Transaction Server Installation Requirements

The following table lists the hardware and software installation requirements for the Argus Transaction Server.

Requirement Type | Requirement Description | Small | Mid-Sized | Large
--- | --- | --- | --- | ---
Software | Windows 2008 SP2 Standard/Enterprise (32-bit) Windows 2008 R2 Standard/Enterprise (64-bit) (English version for all above OS) | X X | X X | X X
| RightFax 9.4 * | X | X | X
| Oracle Standard/Enterprise, Version 11.2.0.1/ 11.2.0.3 (11.2.0.1/ 11.2.0.3 Client, 32-bit only) | X | X | X
| Oracle 11.2.0.1/ 11.2.0.3 OLE Objects/ Oracle ODP.net 11.2.0.1 / 11.2.0.3 | X | X | X
| Oracle ODAC 11.2.0.1/ 11.2.0.3 | X | X | X
| E-mail Support SMTP | X | X | X
| Microsoft Excel/Word 2007 * (32 bit) Microsoft Excel/Word 2010 (32 bit) | X | X | X
| Microsoft XML Parser 6.0 | X | X | X
| Visual C++ 2008 SP1 Runtime | X | X | X
| Microsoft .NET 3.5 Framework | X | X | X
| Oracle Access Manager 10gR3 (10.1.4.3) | X | X | X
| Axway Synchrony, Version 5.9 SP1/5.10 (64-bit) (Optional) |  |  | X
| Documentum DFC, Version 6.5 SP2/SP3 (Optional. Installed only when using Documentum with AG Service and/or Interchange Service) * | X | X | X
| Adobe Acrobat Reader, Version 9.3.4 * | X | X | X
Hardware | 1 CPU X 3 GHz, 4GB Memory/CPU | X |  |
| 2 CPUs X 3 GHz, 4 GB Memory/CPU |  | X | X
| Physical Server or Oracle Virtual Machine 2.2.1/2.2.2 | X | X | X
| Minimum Resolution 1280X1024 | X | X | X

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. The IIS server is required for Transaction Server only for the Integrations module.

### Argus Interchange Server Requirements

The following table lists the hardware and software installation requirements for the Argus Interchange Transaction Server.

Requirement Type | Requirement Description | Small | Mid-Sized | Large
--- | --- | --- | --- | ---
Software | Windows 2008 SP2 Standard/Enterprise (32-bit) Windows 2008 R2 Standard/Enterprise (64-bit) (English version for all above OS) | X X | X X | X X
| RightFax 9.4 (Optional) * | X | X | X
| Oracle Standard/Enterprise, Version 11.2.0.1/ 11.2.0.3 (11.2.0.1/ 11.2.0.3 Client, 32-bit only) | X | X | X
| Oracle 11.2.0.1/ 11.2.0.3 OLE Objects/ Oracle ODP.net 11.2.0.1 / 11.2.0.3 | X | X | X
| Oracle ODAC 11.2.0.1/ 11.2.0.3 | X | X | X
| E-mail Support SMTP | X | X | X
| IIS, Version 7.0 IIS Version 7.5 (Windows 2008 R2 on 64-bit) | X | X | X
| Microsoft Excel/Word 2007 (32 bit) Microsoft Excel/Word 2010 (32 bit) | X | X | X
| Axway Synchrony, Version 5.10 SP1 (64-bit) (Optional*) |  |  | X
| Microsoft XML Parser 6.0 | X | X | X
| Visual C++ 2008 SP1 Runtime | X | X | X
| Microsoft Visual Basic Power Packs 3.0 (Mapping Only) | X | X | X
| Microsoft .NET 3.5 Framework | X | X | X
| Documentum DFC, Version 6.5 SP2/SP3 (Optional. Installed only when using Documentum with AG Service and/or Interchange Service) * | X | X | X
Hardware | 1 dual core CPU X 3 GHz, 4 GB Memory/CPU | X |  |
| 2 CPUs X 3 GHz, 4 GB Memory/CPU |  | X | X
| Physical Server or Oracle Virtual Server 2.2.1 / 2.2.2 | X | X | X
| Minimum Resolution 1280X1024 | X | X | X

### Argus Safety Web Client Installation Requirements

The following table lists the hardware and software installation requirements for the Argus Safety Web Client.

Requirement Type | Requirement Description | Small | Mid-Sized | Large
--- | --- | --- | --- | ---
Software | Windows 7 (32-bit) (English and Japanese) Windows XP Pro SP3 (32-bit) (English and Japanese) | X | X | X
| Microsoft Internet Explorer (one of the listed versions) Internet Explorer 8.0/9.0 (English versions on English OS and Japanese versions on Japanese OS) | X | X | X
| Microsoft Word/Excel (one of listed versions) Microsoft Word/Excel 2007 Microsoft Excel/Word 2010 (English versions on English OS and Japanese versions on Japanese OS) | X | X | X
| Adobe Acrobat Reader, Version 9.3.4 (English versions on English OS and Japanese versions on Japanese OS) | X | X | X
Hardware | Pentium IV, 3 GHz, 2 GB RAM (minimum) | X | X | X
| Minimum Resolution 1280X1024 | X | X | X

On the web client system, a new window may open (instead of opening in the same application window) when you try to view a 2007 Microsoft Office program document from the Argus Application in Windows Internet Explorer 8 or Internet Explorer 9. Please refer to the following Microsoft article for more information and workaround:

http://support.microsoft.com/kb/927009

### Argus Safety Dossier Web Client Installation Requirements

The following table lists the hardware and software installation requirements for the Argus Safety Dossier Web Client.

Requirement Type | Requirement Description | Small | Mid-Sized | Large
--- | --- | --- | --- | ---
Software | Windows XP Pro SP3 (32-bit) (English and Japanese) Windows 7 (32-bit) (English and Japanese) | X | X | X
| Microsoft Internet Explorer (one of the listed versions) Internet Explorer 8.0/9.0 (English versions on English OS and Japanese versions on Japanese OS) | X | X | X
| Adobe Acrobat Reader, Version 9.3.4 (English versions on English OS and Japanese versions on Japanese OS) | X | X | X
| Word/Excel 2007 Word/Excel 2010 (English versions on English OS and Japanese versions on Japanese OS) | X | X | X
Hardware | Pentium IV, 3 GHz, 2GB RAM (minimum) | X | X | X
| Minimum Resolution 1280X1024 | X | X | X

### Argus End of Study Unblinding Tool (EOSU) Installation Requirements

The following table lists the hardware and software installation requirements for the Argus End of Study Unblinding Tool (EOSU).

Requirement Type | Requirement Description | Small | Mid-Sized | Large
--- | --- | --- | --- | ---
Software | Windows XP SP3 | X | X | X
| Windows 7 | X | X | X
| Windows 2008 SP2 Standard/Enterprise (32 bit)Windows 2008 R2 Standard/Enterprise (64 bit) | X | X | X
| Oracle Client 11.2.0.1/11.2.0.3 | X | X | X
| Oracle OLE Objects 11.2.0.1/11.2.0.3 | X | X | X
| Oracle ODAC 11.2.0.1/11.2.0.3 | X | X | X
| Microsoft Excel 2007 / 2010 (32-bit) | X | X | X
| Visual C++ 2008 SP1 Runtime | X | X | X
Hardware | 1 Dual Core CPU x 3Ghz, 4 GB RAM | X | X | X
| Minimum Resolution 1280 x 1024 | X | X | X

### Argus Multi-Tenant Portal Server Requirements

Argus multi-tenant users should install and configure WebCenter 11.1.1.4 (on WebLogic 10.3.4) on a separate server. This component is optional and is required only for multi-tenant installations to deploy global homepage and its portlets.

## Argus Safety Hardware Topology

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

### Recommended Hardware Topology for a Small Company

The following is our definition of a small company:

- A small company is a company with fewer than 50 concurrent users and fewer than 200 new cases reported each month.

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

### Recommended Hardware Topology for a Mid-sized Company

The following is our definition of a mid-sized company:

- A mid-sized company is a company with 50 to 100 concurrent users and 300 to 600 new cases reported each month.

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

### Recommended Hardware Topology for a Large Company

The following is our definition of a large company.

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

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

## 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/Report 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.

## 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

Note: In the 7.0.1 release, merging of databases into a Multi-Tenant Database does not support merging of DLP data.