Agile software development methods are
the most popular used today. However, agile methods were initially thought to be limited to small projects with co-located teams,
in non-safety-critical domains. In the past 10
years, our research has focused on the first
two constraints; agile methods are now often
used for large projects with distributed development teams. The use of agile methods in
regulated environments represents the final
frontier. Recently, we embarked on a study of
the use of agile methods in QUMAS, a leading
supplier of Quality Management and Compliance Solutions for the life-sciences/pharma domain. We created a new agile method
which has yielded positive impacts including
quicker customer feedback and a shorter
regulatory conformance assessment process.
Furthermore, QUMAS were recently acquired
by a larger overseas company, and used this
research to prove the expertise of the Irish software development function, strengthening
the case for retaining high value jobs in Ireland.