I am currently pursuing my Masters in Software Engineering at the University of Minnesota. I am in the class of 2008 and in October 2007, I have identified a Capstone project that I will be pursuing.
My project is to develop a process for developing standardized Validation protocol for commonly used software components. I will be using the FDA guidelines as a start for understanding what is needed for software validation. From there, I will abstract components that are often reusable in the systems that we build. Like the concept of modular code, this project is to modularize software validation.
The critics would say that all systems are different and I would agree that it is different in the machine functionality but there are similar and functionalities that are always present in the systems that we build and this will provide a wrap-around validation protocol.
I will be working with Prof Dick Hedger who taught one of the classes I took in Spring 2007 (Software Process Improvement). The project is divided into 3 phases - first is the research phase to come up with the guildeline. The second phase will use this process to develop 3 sample validation protocols. The third and final phase will be to integrate this process into our existing Quality System.
Update 4/9/2008: Finally, after months of work, I think I am at a point where I’m ready for my final paper report and presentation this coming Saturday.
