Abstract

It is generally assumed among software developers and managers that a document-driven development process is incompatible with an agile development process. There are few reports on this issue and even less empirical research documenting the assumed incompatibility. More and more software companies however have a desire to adopt agile development processes while maintaining compliance with a quality assurance standard or even a process standard. We have studied the software development process of a Danish pharmaceutical company. For market reasons the company has to comply the US Food and Drug Administration’s standards for software development. The company has also successfully implemented significant parts of the agile methodology Scrum. We describe this case and we analyse using Soft Systems Methodology how well the development process combines these diverging sets of process requirements. We find that despite much effort the agile development process suffers from its adaptation to the FDA standard, but at the same time many of the genuine qualities of an agile process have been maintained. From this case study we discuss the implications for development companies facing the challenge of implementing a mixed development approach.

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