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Project Management and Testing for Standardized Tracking System

 
INDUSTRY
Bioscience
SERVICES
Project Management
Total Quality Management
Regulatory Compliance
SKILLS
QA and Testing
Quality Analysis
Data Management
Created knowledge base for metrics.
The Challenge

Our client’s Regulatory Affairs Group needed to establish a standardized tracking system to identify when their regions update local labeling/prescribing information. To move from the current manual process to an automated process, our client needed to implement and tailor an off-the-shelf “Global Decision Tracking Portal.” The Regulatory Affairs Group with approximately 700 end users and professionals, establishes credibility with regulatory agencies, successful product registrations, and compliance worldwide based upon new regulatory requirements.

The Solution

Our consulting team provided the following core project activities:

  • Application testing
  • Configuration of the infrastructure environment
  • Infrastructure Installation Qualification (IQ) test case creation, execution, report development and final resolution to test incidents
  • Software Operation Qualification (OQ) test case creation, execution, report development and final resolution to test incidents
  • Business Team member support in writing UAT test cases and database development/administration
The Result

Our solution provided:

  • A process to track company affiliates implementation of core data and safety information sheet updates
  • Assurance that the labeling/prescribing information is synchronized and that all key safety messages are contained in each respective global labeling file
  • A knowledge base for providing metrics on regional and local labeling changes
  • A streamed-lined business process for tracking label changes

We successfully moved our client’s standardized tracking system from a manual to automatic process. This project was completed on time and within budget.