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 Argus Safety Database Server

Components Software Required
Operating System As certified by the Oracle Database version.
Oracle Database Oracle 12.1.0.2

(supports both Standard Edition 2 (SE2) or Enterprise Edition over the CDB/PDB or traditional Non-CDB database format.)
Other Oracle Database Components (Optional)
  • Oracle Advanced Security Transparent Data Encryption (TDE)*

  • Oracle Advanced Security Network Encryption

  • Oracle XML Developer's Kit (XDK)

    (Required only for PMDA R3 Paper Reports)

  • Tablespace with 500MB free space to create Argus Unblinding Schema in Argus Safety Schema.

* Note:

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.

1.2.2 Argus Safety Web Server

Note:

Components Software Required
Operating System
  • Microsoft Windows 2012 Standard

  • Microsoft Windows 2012 R2 Standard
Oracle Client
  • Oracle 12c Release 1 Client 12.1.0.2 (32-bit only)

  • Oracle Call Interface

  • ODAC

  • MTS

  • ODP.NET
Other Software (Required)
  • Microsoft Visual C++ 2005 SP1 Redistributable Package MFC Security Update (32-bit)

  • Microsoft Visual C++ 2012 Runtime

  • Microsoft .NET 3.5 SP1 Framework

  • Documentum DFC 7.2 or 6.7 SP2 (64-bit)
Other Software (Optional) Documentum DFC 7.2 or 6.7 SP2 (64-bit)
Oracle WebCenter (Deprecated) Argus Safety no longer supports Oracle WebCenter.

While upgrading, if this component appears, uncheck it.

1.2.3 Argus Safety Transaction Server

Recommendation:

Do not run Argus Safety Service or ESM Service on the Web Server, because the agproc.exe and argusvr2.exe services might conflict with each other when running together.
Components Software Required
Operating System
  • Microsoft Windows 2012 Standard

  • Microsoft Windows 2012 R2 Standard
Oracle Client
  • Oracle 12c Release 1 Client 12.1.0.2 (32-bit only)

  • Oracle Call Interface

  • ODAC

  • MTS

  • ODP.NET
Other Software (Required)
  • Java JDK 1.8

  • Microsoft Visual C++ 2005 SP1 Redistributable Package MFC Security Update (32-bit)

  • Microsoft Visual C++ 2012 Runtime

  • Microsoft .NET 3.5 SP1 Framework
Other Software (Optional)
  • Documentum DFC 7.2 or 6.7 SP2 (64-bit)

  • RightFax 10.6 -Required files only

1.2.4 Argus Interchange Server (Optional)

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

Components Software Required
Operating System
  • Microsoft Windows 2012 Standard

  • Microsoft Windows 2012 R2 Standard
Oracle Client
  • Oracle 12c Release 1 Client 12.1.0.2 (32-bit only)

  • Oracle Call Interface

  • ODAC

  • MTS

  • ODP.NET
Other Software (Required)
  • Microsoft Visual C++ 2005 SP1 Redistributable Package MFC Security Update (32-bit)

  • Microsoft Visual C++ 2012 Runtime

  • Microsoft .NET 3.5 SP1 Framework
Other Software (Optional) Documentum DFC 7.2 or 6.7 SP2 (64-bit)

1.2.5 Argus Safety Web Client

Components Software Required
Operating System
  • Microsoft Windows 7 (32 or 64-bit)

  • Microsoft Windows 8.1 (32 or 64-bit)

  • Microsoft Windows 10 (32 or 64-bit)*
Browser Microsoft Internet Explorer, Version 11.0 (32 or 64-bit) - Compatibility View only
Oracle Client
  • Oracle 12c Release 1 Client 12.1.0.2 (32-bit only)

  • Oracle Call Interface

  • ODAC

  • MTS

  • ODP.NET
Other Software (Required) Adobe Acrobat Reader DC/XI with East Asian Fonts
Other Software (Optional)
  • Microsoft Office (32 or 64-bit)

  • Oracle BI Publisher 12.2.1

* To apply 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:

  1. 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

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

1.2.6 Argus Unblinding, Schema Creation Tool and Interchange Mapping Tool

Components Software Required
Operating System
  • Microsoft Windows 2012 Standard

  • Microsoft Windows 2012 R2 Standard
Operating System—Windows Client Machine
Browser Microsoft Internet Explorer, Version 11.0 (32 or 64-bit) - Compatibility View only
Oracle Client
  • Oracle 12c Release 1 Client 12.1.0.2 (32-bit only)

  • Oracle Call Interface

  • ODAC

  • MTS

  • ODP.NET
Other Software (Required)
  • Microsoft Visual C++ 2005 SP1 Redistributable Package MFC Security Update (32-bit)

  • Microsoft Visual C++ 2012 Runtime

  • Microsoft Visual Basic Power Packs 10.0—Required for Interchange Mapping Tool

  • Microsoft .NET 3.5 SP1 Framework

  • Adobe Acrobat Reader DC/XI

1.2.7 Argus Safety OBIEE or BI Publisher Server

The OBIEE or BI Publisher Server installation is optional, and required only if Argus Safety Flexible Aggregate Reporting (FAR) is enabled or Japanese PMDA R3 Paper Forms need to be generated.

Argus 8.1.1 supports OBIEE or BI Publisher 12.2.1.

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

1.2.8 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.
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
Faxing capabilities for Expedited Reports RightFax 10.5 or 10.6
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.

  • Axway Interchange 5.12 SP8 (64-bit)