ABSTRACT
This chapter demonstrates how processes of good software development and validation provide opportunities for software to be efficiently focused on intended outcomes, for errors to be detected early and for users to thoroughly understand the code. However, even if the software is developed in-house, for use within one institution, the software development process benefits from being managed under an appropriate quality management system, and this is even a requirement under the new EU Medical Device Regulation for Medical Device Software. The chapter uses the FDA's guidance as a framework to demonstrate the process of software validation, with reference to the more-recent International Electrotechnical Commission standard, using the example of a project that involved the development of in-house software for analysing radiochromic film measurement data. The key to adopting a good software development process, for any software development project, is the identification and use of a suitable software validation framework.
