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Background A growing research-based Biopharmaceutical manufacturer.

The Objective Analyze current CSV processes to provide a system deployment roadmap with an improved simplification of CSV procedures.

Business Issue This company was in need of an updated strategy for their ERP system with sustainable Computer System Validation (CSV) processes while ensuring compliance with regulatory requirements.

The Solution

  • Conferred with company management to understand their Enterprise Resource Planning (ERP) system validation needs. 
  • Conducted a walkthrough of validation artifacts to understand current state challenges and limitations. 
  • Ensured alignment of recommended strategy with client compliance framework by examining company policies and procedures that included Computer Software Validation (CSV), Failure Mode and Effects Analysis (FMEA), and Software Development Life Cycle (SDLC).
  • Evaluated testing and deployment cycles that included data conversion and migration processes. 
  • Delivered validation discovery observations.
  • Recommended steps to achieve desired future state for ERP strategy and a sustainable CSV process.