1 System Requirements

1.1 Argus Safety Recommended Hardware Topology

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

1.1.1 Small Company

(1 to 50 concurrent users, fewer than 200 new cases reported each month)

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1.1.2 Mid-sized Company

(51 to 100 concurrent users, 300 to 600 new cases reported each month)

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1.1.3 Large Company

(Over 100 concurrent users, 1000 to 5000 new cases reported each month)

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1.1.4 Hardware Requirements for Argus Safety

  • Argus Safety Database Server

    Hardware Requirements Small Mid-Sized Large
    RAM 4-8 GB 8-16 GB 16-32 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) Optional Optional Optional
    Oracle RAC 12c R1 (with 12.1.0.2) Optional Optional Optional

  • Argus Safety Web Server, Transaction Server, and Interchange Server

    Hardware Requirements Small Mid-Sized Large
    RAM 4 GB 4 GB 4 GB
    CPU or Processor 1 Dual Core CPU x 3 GHz 2 Dual Core CPUs x 3 GHz 2 Dual 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

  • Argus Safety Web Client

    • RAM: 2 GB

    • Pentium IV x 3 GHz

    • Minimum Resolution: 1280 x 1024

  • Argus End of Study Unblinding Tool

    • RAM: 4 GB

    • 1 Dual Core CPU x 3 GHz

    • Minimum Resolution: 1280 x 1024

1.2 Software Requirements for Argus Safety

1.2.1 Operating System

Operating System DB Server Web Server Transaction Server Interchange Server Web Client Argus Unblinding Schema Creation Tool Interchange Mapping Tool
  (As certified by the Oracle Database version)  
Microsoft Windows 2012 R2 Standard Yes Yes Yes Yes Yes Yes
Microsoft Windows 7 (32/64-bit) Yes
Microsoft Windows 8.1 (32/64-bit) Yes
Microsoft Windows 10 (32/64-bit) Yes

1.2.2 Oracle Components

Oracle Components DB Server Web Server Transaction Server Interchange Server Web Client Argus Unblinding Schema Creation Tool Interchange Mapping Tool
Oracle Database Server version 12.1.0.2(Enterprise/Standard Edition 2 over CDB/PDB or non-CDB format) Yes  
Oracle Advanced Security Transparent Data Encryption (TDE) Optional
Oracle Advanced Security Network Encryption Optional
Oracle XML Developer's Kit (XDK) Optional(Required only for PMDA R3 Paper Reports)
Oracle 12c Release 1 Client 12.1.0.2 (32-bit only) with Patch 19720843

(See Section 1.2.6, "Install and Apply Oracle Patch")

Yes Yes Yes Yes Yes Yes
Oracle Call Interface Yes Yes Yes Yes Yes Yes
ODAC Yes Yes Yes Yes Yes Yes
MTS Yes Yes Yes Yes Yes Yes
ODP.NET Yes Yes Yes Yes Yes Yes

1.2.3 Other Components

Other Components DB Server Web Server Transaction Server Interchange Server Web Client Argus Unblinding Schema Creation Tool Interchange Mapping Tool
Microsoft Internet Explorer, Version 11.0 (32/64-bit) - Compatibility View only Yes  
Java JDK 1.8 or above Yes
Microsoft Visual C++ 2012 Runtime Yes Yes Yes Yes Yes Yes
Microsoft Visual Basic Power Packs 10.0 Yes
Microsoft .NET 3.5 SP1 Framework Yes Yes Yes Yes Yes Yes
Microsoft Word and Excel (32/64-bit) Yes
Adobe Acrobat Reader DC/XI with East Asian Fonts Yes
Adobe Acrobat Library up to 1.7 Yes Yes

1.2.4 Generic—Other Supported Features (Optional)

If you are using... You must install...
Single Sign-On Oracle Identity Manager (OIM) 11.1.2.2 - WebGate 10.1.4.3 (32-bit only) integration with Oracle Identity Manager.
Built-in Reports to run the PMDA E2B R3 Paper Reports or Flexible Aggregate Reporting
  • Oracle Business Intelligence Enterprise Edition (OBIEE) 12.2.1.0 with Patch 21918899 (fonts only)
  • Oracle BI Publisher 12.2.1.0 with Patch 21918899 (fonts only) (for Argus SE only)

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

See Chapter 17, " 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 5.12 SP8+—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, Version 6.7 SP2 (64-bit), or 7.2 on Web, Transaction, and Interchange Servers.
Faxing capabilities for Expedited Reports RightFax 10.6 on Transaction Server.
E2B Reporting for exchange
  • Oracle B2B - 12.2.1—Certified with both AS1 and AS2 protocols for E2B exchanges between regulatory authorities and pharmaceutical companies.

    Apply patch 21836754 to support AES encryption.

  • Axway Interchange 5.12 SP8 (64-bit)


1.2.5 Oracle Advanced Security Transparent Data Encryption (TDE)

Oracle Database TDE feature is part of the Oracle Advanced Security option available for Oracle Database Enterprise Edition 12c (https://docs.oracle.com/database/121/ASOAG">>, or

http://www.oracle.com/technetwork/database/options/advanced-security/overview/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.

1.2.6 Install and Apply Oracle Patch

To apply Oracle Client Patch required for the Schema Creation Tool:

  1. Download and install the patch 19720843: WINDOWS DB BUNDLE PATCH 12.1.0.2.1 through Oracle Support.

  2. Set oracle_home to your client home location.

    For example:

    1. SET ORACLE_HOME=C:\app\client32\product\12.1.0\client_1

    2. Go to %oracle_home%\bin\ of the client.

    3. Copy file "oranfsodm12.dll" present in "\p19720843_121020_WINNT\19720843\files\bin\" and paste it under %oracle_home%\bin.

  3. Run sqlldr help=y or sqlldr.exe.