Improving the custom-built applications computerized system validation lifecycle for a medical device company

Abstract

This research project was focused in the improvement of the Custom-Built Applications Computerized System Validation Lifecycle for a Medical Device Company. A Computerized System Validation is the process of documenting the deliverables of a system with the purpose of showing fulfillment of the requirements. The Custom-Built Applications Computerized System Validation Lifecycle was improved by reducing the Production Lead Time from 502.66 days to 307.09 days. This improvement reduced the timeline by 195.67 days. This represents a reduction of 39% of the waste. Additionally, the amount of forms that are generated through the lifecycle were reduced from 26 forms to 13. The waste in form development was reduced by 50%. In the present, the Custom-Built Applications Computerized System Validation Lifecycle cost is $46,256.00. As a result, these improvements represent a saving for the Medical Device Company of $17,976.00 per each Custom-Built Applications Computerized System Validation Lifecycle. This represents 39% of cost reduction. Key Terms ⎯ Computerized System Validation, Custom-Built Applications, Medical Device, Software Tool Regulations.