Investigating the Capability of Agile Processes to Support Life-Science Regulations: The Case of XP and FDA Regulations with a Focus on Human Factor Requirements

摘要

Recently, there has been a noticeable increase of attention to regulatory compliance. As a result, more and more organizations are required to comply with the laws and regulations that apply to their industry sector. An important aspect of these regulations is directly related to the way by which software systems, used by regulated companies, are built, tested, and maintained. While some of these regulations require from these systems to support a very specific set of requirements, others, the focus of this paper, are concerned with the process by which the system has been built. The Food and Drug Administration (FDA) regulations, for example, impose stringent requirements on the process by which software systems used in medical devices are developed. One particular focus of the FDA regulations is on having a user-centered approach for building software for medical devices through the use of well-known concepts in the area of human factor engineering. In this paper, we discuss these requirements in detail and show how Extreme Programming, an agile process, lacks the necessary practices to support them. We also propose an extension to XP, that if adopted, we believe it will address this particular need of the FDA regulations for medical device software.