First Advisor

Karlin, Sue

Second Advisor

Gerber, Joseph

College

College for Professional Studies

Degree Name

MS Computer and Information Technology

School

School of Computer & Information Science

Document Type

Thesis - Open Access

Number of Pages

68 pages

Abstract

This thesis describes a technical solution that improved the software development efforts needed to verify and validate a medical device, herein referred to as the “medical device.” The medical device had many software and hardware configurations that had to be developed, integrated, managed, and tested. There were a number of problems with the manual processes that were being used to verify and validate the product, so this project developed a system called the “Software Assembly Line” to continuously build software and automatically test it on multiple hardware configurations. As a result, software quality and predictability were improved, and the number of cycles required for formal verification and validation was reduced. The final project recommendation was to validate the Software Assembly Line according to 21CFR820.75, Process Validation.

Date of Award

Spring 2007

Location (Creation)

Denver, Colorado

Rights Statement

All content in this Collection is owned by and subject to the exclusive control of Regis University and the authors of the materials. It is available only for research purposes and may not be used in violation of copyright laws or for unlawful purposes. The materials may not be downloaded in whole or in part without permission of the copyright holder or as otherwise authorized in the “fair use” standards of the U.S. copyright laws and regulations.

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