RxLogix Corporation SOP

Argus Safety Administration SOP

Effective Date: 14-Feb-2020

Document Number: SOP-013

Version: 4.0

Confidentiality
This document contains proprietary information. Unauthorized copying or disclosure is
prohibited.
RxLogix firmly believes in maintaining the highest principles of professional ethics and
adheres to the confidentiality agreements of the respective parties. RxLogix has demonstrated
the ability to develop quality solutions while maintaining full confidentiality.
 DOCUMENT NUMBER
Standard Operating Procedure SOP-013
STATUS EFFECTIVE DATE VERSION NUMBER PAGE NO
Effective 14-Feb-2020 4.0 2 of 6
TITLE Argus Safety Administration

Revision History

Version Author Date Description of Change

1.0 Not captured 25-May-2012 Reviewed and Approved first baseline

2.0 Gourav Duggal 31-Aug-2016 As per 2016 Periodic Review, no changes

were needed for this SOP.

3.0 Geetika Choudhary 12-Apr-2019 Removed reference of CIMS (Change and

Issue Management System) and updated
with JIRA.

4.0 Geetika Choudhary 30-Jan-2020 Ported to new SOP template and included
reference of SOP-011 Change Management

Template: RxL-TMP-SOP-001, Version 7.0; Effective 01-Aug-2019

 DOCUMENT NUMBER
Standard Operating Procedure SOP-013
STATUS EFFECTIVE DATE VERSION NUMBER PAGE NO
Effective 14-Feb-2020 4.0 3 of 6
TITLE Argus Safety Administration

Table of Contents
1.0 PURPOSE ..................................................................................................................................4
2.0 SCOPE .......................................................................................................................................4
3.0 GENERAL ..................................................................................................................................4
3.1 DEFINITIONS .............................................................................................................................4
3.2 REFERENCES ............................................................................................................................4
3.3 ROLES AND RESPONSIBILITIES ...................................................................................................5
4.0 PROCEDURE .............................................................................................................................5
4.1 ROUTINE MAINTENANCE ACTIVITIES ...........................................................................................5
4.2 REPORTING CONTACT AND SENDER INFORMATION MANAGEMENT ................................................5
4.3 USER ACCOUNT MANAGEMENT ..................................................................................................5
4.4 APPLICATION ISSUE MANAGEMENT .............................................................................................6
4.5 APPLICATION UPDATES..............................................................................................................6
4.6 DISASTER RECOVERY................................................................................................................6
4.7 DEFECT AND ENHANCEMENT TRACKING .....................................................................................6
 DOCUMENT NUMBER
Standard Operating Procedure SOP-013
STATUS EFFECTIVE DATE VERSION NUMBER PAGE NO
Effective 14-Feb-2020 4.0 4 of 6
TITLE Argus Safety Administration

1.0 PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to document administration and
maintenance procedures for Argus Safety for which the components are listed below. These
administration and maintenance tasks are required to keep the system functional, secure, and in a
validated state.
.

2.0 SCOPE
This SOP applies globally to RxLogix staff, contract workers, vendors and clients responsible for
maintaining and supporting RxLogix hardware and software.

This SOP applies to all CRS configuration items and supporting controlled environments, (test,
production, training and disaster recovery) maintained by RxLogix and managed through the
Configuration Management.

3.0 GENERAL
3.1 Definitions
See GDL-001 Glossary for the definitions of terms and abbreviations.

SOP-specific terms and abbreviations are defined in the table below.

Term / Abbreviation Definition

RxLogix Support RxLogix’s issue management system for clients to utilize to report incidents and
Portal (JIRA System) service requests
CRS Computer Related System
GxP Regulatory Good Practices. The ‘x’ represents the specific descriptor. GxP
regulations include Good Manufacturing Practice (GMP), Good Clinical Practice
(GCP) & Good Lab Practice (GLP).

3.2 References

Document ID Document Title

GDL-001 Glossary
QM-001 Quality Manual
SOP-022 Document Management Plan
SOP-032 Record Retention
SOP-011 Change Request Management
 DOCUMENT NUMBER
Standard Operating Procedure SOP-013
STATUS EFFECTIVE DATE VERSION NUMBER PAGE NO
Effective 14-Feb-2020 4.0 5 of 6
TITLE Argus Safety Administration

3.3 Roles and Responsibilities

Role Responsibilities
RMS Team RxLogix Argus Managed Services Team
The person/group from the client side responsible for raising
Client Team request, reviewing or providing more information on the
Requirement

4.0 Procedure

4.1 Routine Maintenance Activities

 RxLogix is responsible for monitoring the systems and resolving application or integration
failures. Activities required to address failures will be supported through service requests or
incidents in JIRA.
 Application Administration and Business Support Administration are responsible for monitoring
the systems and resolving application or integration failures. Activities required to address
failures will be supported through service requests or incidents in JIRA
o Review JIRA for any open service request or incidents. All service requests and
incidents are stored within JIRA.
o Review Extract, Transform, Load (ETL) execution status.
o Review E2B failures.
o Monitor Oracle service log for alert rule execution status.
o Review ESM logs for errors and remediate any errors found. Ensure that log files are
being updated at the correct interval.
o Monitor and restart services if they are in a hung state.
o Review Duplicate search functionality and resolve issues if needed.
o Resolve issues with Perceptive services for alerts.
o Monitor disk space of file servers and database.
o Resolve orphaned processes running.
o Resolve and recreate zombie Oracle jobs.
o Review import and export folders for backlogged files.
o Review actions that ensure systems are synchronized.
o Review schedule report execution status.

4.2 Reporting Contact and Sender Information Management

 Reporting destinations for non-E2B contacts: Agency addresses, contact information (such as
e-mail addresses, postal address, fax number and telephone numbers (excluding Company
Name, and preferred methods for distribution), will be requested through a service request or
incident within JIRA and fulfilled by the Business Support Administrators.

4.3 User Account Management

 The user account creation, modification, and removal requests will be managed and fulfilled by
Support Administration.
 User account creation, modification, and removal requests can be requested through the JIRA.
 DOCUMENT NUMBER
Standard Operating Procedure SOP-013
STATUS EFFECTIVE DATE VERSION NUMBER PAGE NO
Effective 14-Feb-2020 4.0 6 of 6
TITLE Argus Safety Administration

4.4 Application Issue Management

 System-related issues and problems will be reported through JIRA. RxLogix will log the work
order and resolve or triage the issue to the extent possible. If they are unable to determine a
resolution or triage path, RxLogix will assign the incident/request to the client for further triaging
with the appropriate vendor.

4.5 Application Updates

 RxLogix is responsible for application patch and version upgrade installations.
 Upgrade requests are processed through the JIRA. The request can come from RxLogix or
the client.
 RxLogix will provide a preliminary technical assessment of the items, outlining the technical
impact on the current production system, and an initial recommendation regarding future action
and priority of the item.

4.6 Disaster Recovery

 RxLogix will ensure that the database and server instances are replicated and can be recovered
should the data center fail; the level of redundancy will be agreed upon with the client

4.7 Defect and Enhancement Tracking

Defects and enhancements will be tracked by client and with appropriate vendor
 Category: SOP
Title: SOP-013 Argus Safety Administration

Version State Effective Date Document ID

04 Effective 14-FEB-2020 290730
Printed by kapil.wadhwa@rxlogix.com from app.zenqms.com on 27-Mar-2022 at 10:58:59 AM UTC • Page 7 of 7

REVISION HISTORY
Version 03 Effective on 22-Apr-2019
None
Version 04 Effective on 14-Feb-2020
4.0

DOCUMENT ELECTRONIC SIGNATURES

DOCUMENT APPROVAL WORKFLOW
  Author Approval
Geetika Choudhary
Senior Manager I am the author of this document.
Signed 10:33:20 AM UTC 30-Jan-2020
Geetika.Choudhary@rxlogix.com

  Required Workflow Steps for this Category

Geetika Choudhary RxLOGIX / Author
Senior Manager I am the author of this document.
Geetika.Choudhary@rxlogix.com Signed 10:33:47 AM UTC 30-Jan-2020

Deepak Mahajan RxLOGIX / Approver

Director I have reviewed and approve this document.
deepak.mahajan@rxlogix.com Signed 3:15:12 PM UTC 31-Jan-2020

Jayashree Acharya RxLOGIX / Approver

Director I have reviewed and approve this document.
Jayashree.Acharya@rxlogix.com Signed 7:52:41 AM UTC 03-Feb-2020