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Context

A major pharmaceutical company wanted to improve the quality and robustness of its manufacturing data. In this aim, a phased plan was developed to foster data quality culture and to remediate systems and processes.

 

Objectives

 

  • Improve compliancy regarding good manufacturing principles on data management.
     
  • Ensure data reliability to develop a  competitive advantage.

 

Our Approach

  • Educate employees on data integrity principles to develop a quality culture and foster awareness & detection.
     
  • Identify risks by deploying risk assessments on systems and processes.
     
  • Prioritize actions on critical data impacting product quality.
     
  • Review roles & responsibilities on local and global levels to sustain data integrity in the long term.
     
  • Identify remediation projects generating digital opportunities.
     
  • Manage interdependencies with other projects.
     
  • Establish a data governance board to monitor progress against remedial actions and to monitor operations.
     
  • Develop Key Risk Indicators to measure effectiveness.

 

Results

 

  • Product Quality strengthened
     
  • Productivity increased
     
  • Improvement of compliancy in the company