We present a case study on ImpRec, a recommendation System for Software Engineering (RSSE), tailored for CIA at a process automation company. Several authors have proposed tool support for CIA, but very few tools were evaluated in industry. Change Impact Analysis (CIA) during software evolution of safety-critical systems is a labor-intensive task. While this implementation is confined to a single project, within a single organization it does strengthen the belief that adopting agile methods within regulated domains can reap the same benefits as those acquired in non-safety critical domains. For example, the medical device software development project was completed 7% faster when following agile methods, when compared to if it had been completed in accordance with a plan-driven approach. This implementation showed that not only can agile methods be successfully followed, but it also revealed that benefits were acquired. To demonstrate that agile methods could in fact be adopted when developing regulatory compliant software they were implemented on a medical device software development project. However while they may appear contradictory, they align on key values such as the development of the highest quality software. On face value agile methods appear to be contradictory to regulatory requirements. Despite this, the rate of adoption of agile methods within safety critical domains remains low. They offer the ability to improve development time, increase quality and reduce development costs. Agile methods are gaining momentum amongst the developers of non-safety critical software.
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