Reducing Appraisal Costs in Computer System Validation (CSV): A Risk-Based Auditing Approach Using DMAIC Methodologies

Abstract

Computer System Validation (CSV) in the pharmaceutical industry often relies on test-everything approaches, resulting in excessive Appraisal Costs. This research applies to the Lean Six Sigma DMAIC framework to optimize the validation lifecycle by transitioning to a risk-based approach aligned with FDA Computer Software Assurance (CSA) and ISPE GAMP 5 R2 guidelines. A retrospective analysis of 11 protocols established a historical baseline of 336.0 hours across 42 execution days, requiring 8.20 hours per identified issue. A 2025-specific dataset of 144.0 baseline hours was used for back-testing. Results demonstrated that the risk-based framework reduces validation effort to 103.7 hours (a 28% reduction), saving $2,015 per project cycle while maintaining a 100% detection rate for all 28 critical defects.