1 System Requirements

1.1 Hardware Requirements

  • Database Server

    Hardware Requirements Small Mid-Sized Large
    RAM 16 GB 32GB >=64 GB
    CPU or Processor Equivalent to 2 - 4 Dual Core x 3GHz Equivalent to 4 - 8 Dual Core x 3GHz Equivalent to 16 Dual Core x 3GHz
    Fail Support System (physical standby option) Dataguard Dataguard Dataguard
    Virtualization Optional Optional Optional
    Exadata 12c R1 (with 12.1.0.2 or 12.2.0.1) Optional Optional Optional
    Oracle RAC 12c R1 (with 12.1.0.2 or 12.2.0.1) Optional Optional Optional
    Oracle RAC 19c Optional Optional Optional

  • Web Server, Transaction Server, and Interchange Server

    Hardware Requirements Small Mid-Sized Large
    RAM 8 GB 16 GB 16 GB
    CPU or Processor 1 Dual Core CPU x 3 GHz 2 Dual Core CPUs x 3 GHz 2 Quad Core CPUs x 3 GHz
    Virtualization Physical Server or Oracle Virtual Machine

    (OVM 3.2.10, 64-bit)

    		 Physical Server or Oracle Virtual Machine

    (OVM 3.2.10, 64-bit)

    		 Physical Server or Oracle Virtual Machine

    (OVM 3.2.10, 64-bit)
    Minimum Resolution 1280 x 1024 1280 x 1024 1280 x 1024

  • Web Client

    • RAM: 8 GB

    • 3 GHz Dual Core CPU

    • Minimum Resolution: 1280 x 1024

  • Argus Unblinding Tool

    • RAM: 8 GB

    • 3 GHz Dual Core CPU

    • Minimum Resolution: 1280 x 1024

1.2 Software Requirements

1.2.1 Operating System

Operating System DB Server Web Server Transaction Server Interchange Server Web Client Argus Unblinding Tool Dictionary Management Tool
  Operating System as certified for Oracle 19c, 12.1.0.2 or 12.2.0.1 — — — —   —
Microsoft Windows 2016 — Yes Yes Yes — Yes Yes
Microsoft Windows 2012 R2 Standard — Yes Yes Yes — Yes Yes
Microsoft Windows 10 (64-bit) — — — — Yes Yes —

1.2.2 Oracle Components

Note:

Make sure that you install the same version of Oracle Database Server and Client.
Oracle Components DB Server Web Server Transaction Server Interchange Server Web Client Argus Unblinding Tool Dictionary Management Tool
Oracle Database Server version 19c, 12.1.0.2, or 12.2.0.1(Enterprise/Standard Edition 2 over CDB/PDB or non-CDB format) Yes — — — —   —
Oracle Client version 19c, 12.1.0.2, or 12.2.0.1 (64-bit only) with the latest patch set

(See Section 2.2.3, "Install and Apply Oracle Patch Set")

 — Yes Yes Yes — Yes Yes
MTS — Yes Yes Yes — Yes Yes
ODP.NET — Yes Yes Yes — Yes Yes
Java JRE 1.8 or above — Yes

(Required for Liquibase and WebGate only)

 — — — — Yes
Oracle Advanced Security Network Encryption Optional — — — — — —
Oracle XML Developer's Kit (XDK) Optional(Required only for PMDA R3 Paper Reports) — — — — — —

1.2.3 Other Components

Other Components DB Server Web Server Transaction Server Interchange Server Web Client Argus Unblinding Tool Dictionary Management Tool
Microsoft Internet Explorer, Version 11.0 (64-bit) - Compatibility View only — — — — Yes   —
Microsoft Visual C++ 2010 SP1 Redistributable x64 — Yes Yes Yes — Yes Yes
Microsoft Visual C++ 2015 Redistributable x64 — Yes Yes Yes — Yes Yes
Microsoft Access Database Engine 2016 Redistributable x64 — — — — — — Yes
Microsoft .NET 4.7.2 Framework — Yes Yes Yes — Yes Yes

1.2.4 Generic—Other Supported Features

If you are using... You must install...
Data encryption Oracle Database TDE feature on the Database Server, which is a part of the Oracle Advanced Security option available for Oracle Database Enterprise Edition:

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.
Multi-tenant environment Single Sign-On
Single Sign-On Oracle Identity Management (IDM) version 11.1.2.3

For a multi-tenant environment, install the compatible WebGate version 11.1.2.3.0 (64-bit) and apply the WebGate p26540269_111230_MSWIN-x86-64 bundle patch.
Built-in Reports to run the PMDA E2B R3 Paper Reports or Flexible Aggregate Reporting
  • Oracle Business Intelligence Enterprise Edition (OBIEE) 12.2.1.4

  • Oracle BI Publisher 12.2.1.4 Standalone (for Argus SE only)

  • BI Publisher Desktop tool on the client machine to customize the reports.

  • WebLogic 12.2.1.3

See Chapter 20, " Configure OBIEE or BI Publisher."
LDAP for authentication support LDAP/LDAPS Protocol Version 3.0
E-mail capabilities within Argus SMTP Protocol.

The following Argus Safety components support SMTPS:

  • Argus Safety—Supports SMTPS and TLS 1.2 (Forced). Both Implicit and Explicit modes.

  • Axway B2Bi 2.6 SP1—Supports SMTPS and TLS 1.2. Implicit mode only.

  • OBIEE/BIP—Supports SMTPS and TLS 1.2, and must have JDK 1.8 for SMTPS. Both Implicit and Explicit modes.

Note that B2B does not supports SMTPS.
Documentum for Storage Documentum DFC 7.2 (32-bit) on Web, Transaction, and Interchange Servers.
Faxing capabilities for Expedited Reports RightFax 10.6 (32-bit) on Transaction Server.
E2B Reporting for exchange
  • Oracle B2B 12.2.1.3—Certified with both AS1 and AS2 protocols for E2B exchanges between regulatory authorities and pharmaceutical companies.

    Apply patch 26795544 to support AES encryption.

  • Axway B2Bi 2.6 SP1
Microsoft Windows 2012 R2 Standard IIS 8.5
Microsoft Windows 2016 IIS 10

Tips:

.

  • Enable HTTP Compressions on your windows server.

  • Enable SSL that is supported for your windows server.

1.2.5 General Installation Notes and Information

  • All the information about LDAP, Single Sign-On Header, and SMTP configuration will be synchronized in real-time and also by ETL.

  • Ensure that you have configured the Argus Safety URL in the Argus Safety Load Balancer Server.

    To do so:

    1. Navigate to Argus Console, System Management (Common Profile Switches), and select Network Settings.

    2. In the Argus Safety Load Balancer Server text box, enter either the Argus Safety URL or the Argus Safety Load Balancer URL.