Addressing the Data Integrity Challenge
The Client
- UK-based Pharmaceutical company
- Over 300 people over multiple European locations
- Expanded through merger and acquisition
- Activities include Formulation, Analytical Development and QC testing, Process and Device Development and Pilot Manufacture
The Problem
- Reliance on paper and Excel-based processes
- Wide range of instruments, many of which were not networked
- Manual checking of data was taking more than 30% of scientist and team leaders time
- Merger activity had resulted in inconsistent ways of working
How Digital Lab Consulting Helped
- Interviews with stakeholders to develop thorough understanding of the ‘as is’ situation’, the resulting business implications and desired improvement
- Identified and prioritized the main data integrity gaps and risks
- Provided clear, actionable recommendations for process harmonization
- Developed a tangible, quantifiable RoI to form the basis of a robust business case
- Documented focussed User Requirements Specification (URS) and RFI/RFP
- Supported and guided the vendor selection process
- Project oversight and expertise during deployment and validation
