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

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