The Agile Boundary for Regulated Systems

The cost of documentation is a considerable concern in development of regulated software, and it can be useful to apply the “Agile boundary” concept to software development activities. Consider the generic set of software activities.

With no documentation requirements, you might find great value in applying a high degree of iteration from planning, into requirements, all the way through acceptance test. You might find value leaving requirements to be defined just in time, right before unit implementation begins.

With documentation requirements, however, you might decide that it’s too costly to provide a high degree of iteration in requirements and it’s more cost-effective to use a more Sequential approach. With that in mind, you might draw your Agile boundary after architecture and before software system test: