Training Material

Argus Safety Architecture

Course Number: 0453
Version: 01.00

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 Revision History
Version No. Issue Date Author Description of Change
01.00 13-Apr-2017 N. Rana Initial creation.

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 Agenda
 Why drug safety system?
 Argus Safety – Key features
 Argus Safety Landscape
 High Level Architecture
 Argus Safety Web Server
 Argus Safety Application Server
 Synchrony Server

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 Why Drug Safety System?
 Case Processing: To enter and track the adverse events
 Compliance: To report the cases to regulatory authorities/partners
 Expedited reporting
 Periodic reporting
 Electronic report submission
 Security
 Analysis

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 Argus Safety – Key Features
 User friendly browser based interface, can be accessed from
anywhere over web
 Supports all the major regulatory forms (Expedited / Periodic)
 Electronic exchange of regulatory reports with regulatory
authorities like EMA, FDA
 Fully integrated MedDRA and WHO-Drug browsers
 Inbuilt workflow to manage case processing
 Reporting rules to determine reporting obligations
 Separate web application for business configuration and
administration
 CFR Part 11 compliant
 Fully compliant to guidelines set by ICH for E2B transmission
 Integrates with Fax, Email & LDAP

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 Argus Safety Architecture

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 Argus Safety Web Server
 The Argus web server hosts web pages and business
components that contain the logic for safety data processing.
 This server also provides the integration with the active directory
server for user authentication

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 Argus Safety Web Server - Components
 IIS 7.0 (Internet Information server)
 The Microsoft Internet Information Server (IIS 7.0) hosts the Argus
Safety Web 7.0.1 application.
 .NET framework 3.5
 ASP .NET dynamically generates the Argus Safety Web HTML
pages which can be accessed through Internet explorer.
 Microsoft Visual C++ 2008 Redistributable library & MSXML 6.0
 This library is required by the Argus Safety application COM object.
 Oracle client 11g
 This component is required to connect to the Oracle database.

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 Argus Safety Web Server - Components
 Argus Safety - Application
 The Argus Safety utilizes an out of process COM (Component
Object Model) component (Argusvr2.exe) to process all the incoming
requests and data
 This COM component gets installed as part of the Argus Safety Web
install (C:\Program Files\Oracle\) on Argus Web server
 This component contains all the Argus Safety business logic
 Adobe Reader 8+ and Microsoft Office 2007/2010
 These components are required by the Argus safety application COM
object

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 Argus Safety Application Server
 The Argus application server hosts Argus Interchange and AG
Service.
 AG Service is a windows service that runs in the background
and automates key safety tasks.
 Argus Interchange is an electric submission and exchange
module that enables the transmission of required ICH: E2B
reports as well as the exchange of vital drug safety information
with regulators and partners worldwide.
 Argus Interchange is the integration point between Argus Safety
and the electronic gateway (Synchrony).

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 Argus Safety Application Server - Components
 .NET framework 3.5
 .NET framework is required by the AG Service & ESM Service.
 Microsoft Visual C++ 2008 Redistributable library & MS XML 6.0
 This library is required by the Argus Safety application COM
object.
 Oracle client 11g
 This component is required to connect to the Oracle database.
 Adobe Reader 8+ and Microsoft Office 2007/2010
 These components are required by the Argus safety application
COM object.

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 Argus Safety Application Server - Interchange
 Argus Interchange
 .Argus Interchange provides the ability to electronically submit
expedited reports by using an Electronic Data Interchange (EDI)
gateway (Synchrony).
 Interchange Mapping Client can be used to create new e2b
mapping or to modify existing e2b mappings.
 These mappings are used to translate case data into xml format
specific to reporting destination (e.g. FDA, EMEA, business
partners).
 An e2b mapping for FDA and EMEA comes configured out of
box for use .

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 Sample Argus Safety Landscape Diagram
DSCYPOC DSARXDEV DSARXVAL DSARXPRD
DSARPOC DSARXTRN

Argus Safety Web

PHXPOCARWB-VN01 AGService/Interchange
10.150.136.140 PHXPOCARAP-VN01
ESX VM - 1 CPU, 2 GB RAM 10.150.136.141
ESX VM - 1 CPU, 2 GB RAM
POC DEV-TRN VAL PRD
Oracle 10.2.0.4 Oracle 11.1.0.7 Oracle 11.1.0.7 Oracle 11.1.0.7
PHXUX01 PHXUX06 PHXUX02 PHXUX03
POC DATABASES

Argus Safety Web AGService/Interchange Argus Safety Web AGService/Interchange Argus Safety Web AGService/Interchange
PHXARWBDV-VG01 PHXARAPDV-VG01 PHXARWBVA-VG01 PHXARAPVA-VG01 PHXARWBPD-VG01 PHXARAPPD-VG01
10.150.136.180 10.150.136.181 10.150.136.183 10.150.136.184 10.150.136.186 10.150.136.187
ESX VM - 1 CPU, 1 GB RAM ESX VM - 1 CPU, 1 GB RAM ESX VM - 1 CPU, 2 GB RAM ESX VM - 1 CPU, 2 GB RAM ESX VM - 2 CPU, 2 GB RAM ESX VM - 2 CPU, 2 GB RAM

DEVELOPMENT VALIDATION PRODUCTION

Elan Firewall

DMZ

Synchrony (VAL) Synchrony (PROD)

Synchrony (POC / DEV) PHXSYNCVA-VG01 PHXSYNCPD-VG01
PHXSYNCDV-VG01 10.150.146.31 10.150.136.32
10.150.146.30 1 CPU, 512 MB RAM 1 CPU, 512 MB RAM
1 CPU, 512 MB RAM

Elan Firewall

EMA (TEST) / Regulatory Authority EMA (TEST) / Regulatory Authority EMA (PROD) /Regulatory Authority
(TEST) / Trading Partners (TEST) (TEST) / Trading Partners (VAL) (PROD) / Trading Partners (PROD)

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 Synchrony Server
 Axway Synchrony gateway interfaces with Argus Safety via
Argus Interchange and is an integral component for electronic
submissions of safety data to regulatory agencies and business
partners
 This server hosts the Axway Synchrony gateway solution and is
responsible for external data sharing (e.g. electronic reporting

DMZ
EMEA Gateway

ARGUS Safety/ Argus

Interchange FDA Gateway

Synchrony Server

Business partner or other

Regulatory Agency
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