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Oracle® Argus Safety Installation Guide Release 8.0.1 E68657-01 |
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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

## 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

- 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 offload Interchange Service from the Argus Transaction Server. Alternatively, Interchange Service can be installed on the Transaction Server itself.

- Argus Safety Web Client

  On the web client system, a new window may open (instead of opening in the same application window) when you try to view a Microsoft Office 2007 program document from the Argus Application in Microsoft Internet Explorer 9.

  Refer to the following Microsoft article for more information and workaround:

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

- Argus End of Study Unblinding Tool

- Argus Safety OBIEE/BIP Server

  This server installation is optional and is required only if Argus Safety BIP Periodic Reporting is selected.

  Argus 8.0 supports OBIEE/BIP 11.1.1.7.1.

  Refer to the OBIEE 11g Installation Guide for Hardware and Software requirements.

See Hardware Requirements for Argus Safety for hardware requirements.

## 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 11.2.0.4 / 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.

### Software Requirements for Argus Safety

The following table show the software installation requirements for small, mid-sized, and large companies:

Software Requirements | Argus Safety Database Server | Argus Safety Web Server | Argus Transaction Server | Argus Interchange Server | Argus Safety Web Client | Argus End of Study Unblinding Tool (EOSU) + Schema Creation Tool ** + Interchange Mapping Tool
--- | --- | --- | --- | --- | --- | ---
OPERATING SYSTEM |  |
Microsoft Windows 2008 R2 SP1 |  |
Microsoft Windows 2008 | Yes | Yes | Yes | Yes |  | Yes
IIS Version 7.5 *** |  | Yes |  |  |  |
Microsoft Windows 2012 |  |
Microsoft Windows 2012 | Yes | Yes | Yes | Yes |  | Yes
IIS Version 8.0 *** |  | Yes |  |  |  |
Microsoft Windows 2012 R2 |  |
Microsoft Windows 2012 R2 | Yes | Yes | Yes | Yes |  | Yes
IIS Version 8.5 *** |  | Yes |  |  |  |
Windows Client Machines and Internet Explorer
Microsoft Windows 7 (32/64-bit) |  |  |  |  | Yes | Yes
Microsoft Windows 8 (32/64-bit) |  |  |  |  | Yes | Yes
Microsoft Internet Explorer, Version 9.0 (32-bit) |  |  |  |  | Yes |
Microsoft Internet Explorer, Version 10.0 (32-bit) |  |  |  |  | Yes |
Microsoft Internet Explorer, Version 11.0 (32-bit) |  |  |  |  | Yes |
ORACLE DATABASE SERVER (STANDARD/ENTERPRISE) - VERSION 12C (12.1.0.2) or VERSION 11.2.0.4 *
Microsoft Windows 2008/2012 | Yes |  |  |  |  |
Oracle Enterprise Linux X86/86-64 (Version 5.5.0.0.0/5.7.0.0/6.2/6.4 UEK) | Yes |  |  |  |  |
Sun Solaris 10/11 | Yes |  |  |  |  |
Other Oracle Database Components
Oracle Advanced Security Transparent Data Encryption (TDE)**** | Optional |  |  |  |  |
Oracle Advanced Security Network Encryption | Optional |  |  |  |  |
ORACLE CLIENT
Oracle 11g Client 11.2.0.4 (32-bit only), OLE Objects, ODAC, MTS, ODP.NET |  | Yes | Yes | Yes |  | Yes
Oracle 12c Client 12.1.0.2 (32-bit only), Oracle Call Interface, ODAC, MTS, ODP.NET |  | Yes | Yes | Yes |  | Yes
OTHER MANDATORY SOFTWARE'S |  |
Microsoft Visual C++ 2012 Runtime |  | Yes | Yes | Yes |  | Yes
Microsoft Visual Basic Power Packs 10.0 |  |  |  |  |  | Required for Interchange Mapping Tool
Microsoft .NET 3.5 SP1 Framework |  | Yes | Yes | Yes |  | Yes
Microsoft Word + Excel 2007/2010/2013 (32-bit) |  | Required for Dossier only | Yes | Yes | Yes | Required for Schema Creation MedDRA Recode and End of Study only
Adobe Acrobat Reader with East Asian Fonts |  |  |  |  | Yes |
OPTIONAL SOFTWARE |  |
Documentum DFC Client, Version 6.5 SP2/SP3 Or 6.7 SP2 (64-bit) |  | Yes | Yes | Yes |  |
RightFax 9.4/10.5 -Required files only |  |  | Yes |  |  |
OPTIONAL SUPPORTED FEATURES
Oracle Components
Oracle Access Manager 11g - WebGate 10.1.4.3 (32-bit only) | Required only for Sign-On integration with Oracle Access Manager.
Oracle WebCenter - 11.1.1.7 (on WebLogic 10.3.6) | Required only for multi-tenant installations (Optional - Required only to deploy the Global Application module. Ideally, the WebCenter Portal Server should be deployed on a separate Web Server. Alternatively, the Global Application module can also be deployed on Argus Safety Web Server directly).
Oracle Business Intelligence Enterprise Edition (OBIEE) / BIP - 11.1.1.7.1 |
Third Party Integrations
LDAP/LDAPS Protocol Version 3.0 | LDAP authentication support
SMTP Protocol | E-mail support
Documentum DFC, Version 6.5 SP2/SP3 Or 6.7 SP2 (64-bit) | Required only when Documentum is used for Storage.
RightFax 9.4/10.5 | Required only for faxing Expedited Reports.
Gateway for E2B Reporting
Oracle B2B - 11.1.1.7.0 | Certified with both AS1 and AS2 protocols for E2B exchanges between regulatory authorities and pharmaceutical companies.
Axway Synchrony, Version 5.10.1 (64-bit)/ Version 5.12 SP4 (64-bit) | Required for E2B Report Exchange.

* Note: * Database Instance is required to be AL32UTF8 Character Set. ** Refer to Note 1 for Oracle Client Patch required for Schema Creation Tool. *** Refer to Note 2 for mandatory IIS components. **** Refer to Note 3 for Oracle Database TDE feature.

** Note 1: Oracle Client Patch required for the Schema Creation Tool Download the patch 19720843: WINDOWS DB BUNDLE PATCH 12.1.0.2.1 through Oracle Support. Apply the following workaround after successfully installing this patch: Set oracle_home to your client home location For example: SET ORACLE_HOME=C:\app\client32\product\12.1.0\client_1 Go to %oracle_home%\bin\ of the client Copy file "oranfsodm12.dll" present in "\p19720843_121020_WINNT\19720843\files\bin\" and paste it under %oracle_home%\bin Run sqlldr help=y or sqlldr.exe.

*** Note 2: To install IIS, the following components are required: Web Server > Management Tools IIS Management Console IIS 6 Management Compatibility IIS Management Scripts and Tools Web Server > Application Development ASP ASP.NET 3.5 For web services to work, set the following options: HTTP Activation Non-HTTP Activation Server Side Includes Web Server > Performance Dynamic Content Compression Static Content Compression

**** Note 3: Oracle Database TDE feature is part of the Oracle Advanced Security option available for Oracle Database Enterprise Edition 11g (http://www.oracle.com/technetwork/database/options/advanced-security/index.html). TDE provides the capability to encrypt sensitive data in the Oracle Database in a manner that is transparent to applications. Argus Safety product has been functionally certified with tablespace level encryption using the Oracle Database TDE feature.

## 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.

### Recommended Hardware Topology for a Small Company

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 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 an illustration of the recommended topology for a large company.

### Hardware Requirements for Argus Safety

The following table show the hardware requirements for Argus Safety installation for small, mid-sized, and large companies:

Hardware Requirements | Argus Safety Database Server | Argus Safety Web Server | Argus Transaction Server | Argus Interchange Server | Argus Safety Web Client | Argus End of Study Unblinding Tool (EOSU)
--- | --- | --- | --- | --- | --- | ---
| Small | Mid-Size | Large | Very Large | Small | Mid-Sized | Large | Small | Mid-Sized | Large | Small | Mid-Sized | Large |  |
RAM
2 GB |  |  |  |  |  |  |  |  |  |  |  |  |  | Yes |
4 GB |  |  |  |  | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |  | Yes
4 - 8 GB | Yes |  |  |  |  |  |  |  |  |  |  |  |  |  |
8 - 16 GB |  | Yes |  |  |  |  |  |  |  |  |  |  |  |  |
16 - 32 GB |  |  | Yes | Yes |  |  |  |  |  |  |  |  |  |  |
CPU/Processor
1 Dual Core CPU X 3 GHz |  |  |  |  | Yes |  |  | Yes |  |  | Yes |  |  |  | Yes
2 Dual Core CPUs X 3 GHz |  |  |  |  |  | Yes | Yes |  | Yes | Yes |  | Yes | Yes |  |
Equivalent to 2 - 4 Dual Core X 3GHz | Yes |  |  |  |  |  |  |  |  |  |  |  |  |  |
Equivalent to 4 - 8 Dual Core X 3GHz |  | Yes |  |  |  |  |  |  |  |  |  |  |  |  |
Equivalent to 16 Dual Core X 3GHz |  |  | Yes | Yes |  |  |  |  |  |  |  |  |  |  |
Pentium IV X 3 GHz |  |  |  |  |  |  |  |  |  |  |  |  |  | Yes |
Virtualization
Physical Server |  | Yes | Yes | Yes |  |
Oracle Virtual Machine (OVM 2.2.1/2.2.2) | Optional | Yes | Yes | Yes |  |
Others
Exadata 11g R2 | Optional |  |  |  |  |
RAC 11g R2 | Optional |  |  |  |  |
Minimum Resolution |  | 1280X1024 | 1280X1024 | 1280X1024 | 1280X1024 | 1280X1024

## 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.

## 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 this release, merging of databases into a Multi-Tenant Database does not support merging of DLP data.

## 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