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Essentials of IBM Rational DOORS Next Generation, V5.0

Essentials of IBM Rational DOORS Next Generation, V5.0


Overview

This course teaches analysts and engineers how to define, elaborate, organize, and manage textual and graphical requirements and requirements-related information in IBM® Rational® DOORS Next Generation.

Ration DOORS Next Generation is a key component of the Rational solution for Collaborative Lifecycle Management (CLM). The product provides requirements definition and management capabilities in a fully-integrated environment that can also include IBM® Rational Team Concert™ for change and configuration management, and IBM® Rational® Quality Manager for quality management.

Prerequisites

There are no pre-requisites for this course.

Skills Gained

After completing this course, you should be able to use IBM Rational DOORS Next Generation, part of the IBM jazz based solution for requirements management to:

  • View and work with requirements and other artifacts in a collaborative context
  • Create and edit requirements documents and other artifacts, including both textual and graphical artifacts
  • Create, manage, and view traceability relationships between requirements and other artifacts
  • Manage requirements throughout a project lifecycle

Course Outline

  • View and work with requirements and requirements-related information in a collaborative context
  • Capture, define, elaborate, and edit requirements and requirements-related information, and create hierarchically organized requirements documents
  • Create and manage traceability relationships between requirements and requirements- related information
  • Manage requirements throughout a project lifecycle
Oracle Argus Courses

Oracle Argus Courses

A comprehensive pharmacovigilance platform enabling pharmaceutical manufacturers to improve safety, optimize global compliance, and integrate risk management.

Argus Standard Edition Jumpstart – Online Course

Argus Standard Edition Jumpstart – Online Course

This Argus Standard Edition Jumpstart training helps you develop knowledge and skills to navigate the user interface. Expert Oracle University instructors will teach you how to perform safety case processing using the Argus Standard Edition 7.X and 8.x software.

Course Content:

Argus Standard Edition Fundamentals

Introduction to Argus Standard Edition
The Argus Standard Edition Environment
A Tour of Argus Standard Edition
Processing Safety Cases

Creating a Case in Argus Safety
Entering General Case and Patient Data
Entering Product Data
Entering Event Data
Performing Data Analysis and Reviewing Activities
Performing Code Reviews and Medical Reviews

The Fundamentals of Reviewing Case Safety Data
Performing Code Reviews
Performing Medical Reviews
Entering follow-up information
Performing System Searches

Creating Search Criteria or Advanced Conditions
Creating Hit Lists
Working with the Advanced Conditions Library
Managing Expedited Reporting in Argus Safety

Managing Expedited Reporting in Argus Safety

This Argus Standard Edition 8 Managing Expedited Reporting training is recommended for pharmacovigilance professionals who will be involved with expedited regulatory reporting activities.

Required Prerequisites:

  • Experience with pharmacovigilance concepts and terminiologies
  • Argus Standard Edition Jumpstart – Online Course
  • Argus Standard Edition Processing Safety Cases
Course Content:


Overview of Regulatory Reports

Overview of Expedited regulatory reporting
Regulatory reports available in Argus Safety
Report delivery methods
Examining the reports in worklists
Examining expedited reporting activities
Scheduling Expedited Regulatory Reports

Overview of scheduling expedited regulatory reports
Viewing a list of expedited reports due soon
Scheduling expedited regulatory reports
Generating Expedited Regulatory Reports

Overview of generating regulatory reports
Generating regulatory reports
Transmitting Expedited Regulatory Reports

Overview of transmitting regulatory reports
Transmitting regulatory reports.
Tracking Expedited Regulatory Reports

Overview of tracking regulatory reports
Tracking Regulatory Reports
Schedule Expedited Regulatory Reports through Reporting Rules

Overview of Expedited reporting rules
Configure Expedited Reporting Rule
Auto-Schedule expedited reports
Performing Bulk Reporting

Overview of bulk reporting
AG Services
Auto-Generate expedited reports
Auto-Distribute expedited reports
Force-Distribute expedited reports
Batch Report Generation
Importing E2B Reports

Overview of importing E2B reports
Import pending E2B reports
Accept or Reject E2B report
Differences report
Auto-Accept incoming E2B reports
E2B(R3)

ICH-ICSR Data Element Structure
Case Form Changes
Null Flavors
Amendments to Case and Amendment Reports
Database and Common Profile Switch Changes
Configuring E2B R3 Destination
Transmission and Acknowledgement of E2B(R3) reports
MedWatch Updates

Argus Console Changes
Case Form Changes
MedWatch 3500 A Drug Report Changes
MedWatch 3500 A Device Report Changes
eVAERS

Argus Console Changes
Case Form Changes
Configure eVAERS Destination
Transmission and Acknowledgement of eVAERS reports
Monitoring Regulatory Compliance

Overview of monitoring compliance
Monitor E2B status and compliance
Dashboards features

SOLVE YOUR QUERIES ONLINE

SOLVE YOUR QUERIES ONLINE