Life sciences & chemicals
Data Integrity
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
