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.