A Systematic Approach to Agile Development in Highly Regulated Environments

For established domains within highly regulated environments, a systematic approach is needed to scale agile methods and assure compliance with regulatory requirements. The presented approach works adequately in small agile teams – independently of the underlying method such as Scrum, Kanban, etc. – and is scalable to more and bigger teams or even entire subsidiaries. It is based on a compliance and a quality risk dimension respectively. Both dimensions are needed to fit regulatory requirements in our finance example with more than 100 developers in one subsidiary.