Agile Software Development in Highly Regulated Industries

Every month, more and more software development shops in both product and service based companies have made the switch towards an Agile development methodology. This is leaving the traditional Waterfall methodology, which has been the behemoth methodology framework of the software development world for about 50 years, in the dust. The advantages of an Agile approach does make it a very attractive methodology to adopt: Better team collaboration, building incremental solutions that work, early testing and LESS DOCUMENTATION. Less documentation? Well, that makes every techie in the tech world smile ear to ear. However, when you think about delivering product to the highly regulated space such as in life sciences, food & beverage, etc, the notion of less documentation carries with it a heightened level of risk. Traceability from the basic business requirement through the last parts of validation is crucial to show what was required, what was built and what was tested. Here, at Sparta Systems, we adopted the Agile Scrum methodology back in January 2009. At first, I have to say, we saw immediate benefits due to the advantages that Agile brings. Better team collaboration was probably the first benefit gained. Early testing proved to be a huge benefit. Also, change control was no longer a dirty word. In fact, change control became quite easy to accomplish due to the short iterative cycles the teams worked under. But, early on, we realized that Agile “out of the box” would not meet our needs because of the scrutiny needed to deliver product to the highly regulated industries. As a result, we developed our own adaptation of Agile Scrum (documented in our SDLC SOP, of course) that satisfies documentation and traceability requirements. In effect, we created a hybrid methodology where we start with a waterfall approach to gathering business and functional requirements at a high level, gain complete concurrence/sign off and then commence with the iterative cycles of Agile. As a result, we still maintain the benefits of Agile and, in addition, maintain a lower level of risk through the use of proper documentation and traceability. Even with this, the techies here at Sparta still smile from ear to ear.