A Conceptual Framework for Lean Regulated Software Development

A growing number of companies are discovering that their software development processes must be in compliance with some form of regulation. This is particularly so when it comes to safety-critical or business-critical systems such as Automotive Software, Robotics, Medical Devices or Financial Management systems. These regulations affect the software development process itself in various forms. Furthermore , much attention is being given to ways of improving the efficiency of businesses, for example, by adopting lean principles. This raises the question for how to adopt lean principles for software development within a regulated environment? This poster presents the results of our empirical research into lean and regulated software development. Built from a combination of data sources, we have developed a conceptual framework comprising five primary components. In addition the relationships they have with both the central focus of the framework (the situated software development practices) and with each other are indicated.