Project Management and Testing for Standardized Tracking System
Project Management Total Quality Management Regulatory Compliance
QA and Testing Quality Analysis Data Management
Created knowledge base for metrics.
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.
Our consulting team provided the following core project activities:
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
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.