Client Introduction

With presence in more than 100 countries and regions worldwide, our client is one of the leading independent biotechnology companies in the world. In addition to fighting cancer, cardiovascular disease, osteoporosis, asthma and many other serious illnesses, their innovative medicines have helped millions of people. 

Problem Statement

In order to improve the speed, accuracy, and usability of data analytics capabilities, our client intended to enhance their capability to monitor trending patterns, conduct root cause analysis, and investigate Product Complaints (PCs) and Adverse Events (AEs). Currently, the analysis of these trends is a manual and time consuming process.


We implemented an advanced AI and Enterprise Analytics solution to address the client’s requirements. This solution included the development of a new web application that provides five analytical views, enabling Quality and Safety leadership to:

  • Based on the trends and changes in the number of Product Complaints (PCs) suggested in the view, determine and prioritize areas that require additional investigation or action.
  • Analyze the patterns in product complaints across several qualities during a given time period.
  • Determine if specific material lots are associated with greater complaint rates for a specific end product lot supplied to patients.
  • Filter and scan the notes section of Product Complaints for relevant probing questions and phrases.

Business Benefits

  • Reduced cycle time for investigations and Root Cause Analyses (RCAs).
  • Streamlined data gathering and analysis by eliminating the need for coordination across multiple systems.
  • Automated and accelerated analysis of Product Complaints trends across systems.
  • Improved product compliance, efficiency, and reliability.
  • Decreased occurrence of Adverse Events (AEs) and Complaints, leading to enhanced product quality and continuous improvements.


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