Computer System Validation Cycle Optimization

Abstract

The concept of the project involves the optimization of a current Computer system validation cycle in an active project in the biopharma industry. The root cause for the problem was the excessive amounts of deviations that were being received due to a deficient document generation process. This has been solved by identifying a gap in the review process and putting in place an engineering subject matter expert to review the documents. The end state is reducing the amount of deviations obtained by document at the Quality Assurance level or during the execution. Upon verification, the implementation of technical engineering review layer deviations were reduced to the point of having significant savings towards project managing events. Thus confirming that by having a technical review after generation of the document gaps were reduced to half of what was expected originally. Key Terms ⎯ Computer System Validation (CSV), General Manufacturing Practices (GMP), Food and Drug Administration (FDA).