Systematic Agile Development in Regulated Environments

For established domains within highly regulated environments, a systematic approach is needed to scale agile methods and assure compliance with regulatory requirements. This paper presents a structured method to designing such a systematic approach which works adequately in small agile teams. It is independent 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 which are both needed to fit regulatory requirements. The approach has been validated in the financial IT context with more than 100 developers in one subsidiary.