An Insight into the Difficulties of Software Development Projects in the Pharmaceutical Industry

摘要

Software development projects in the pharmaceutical industry are highly regulated as software failures can have a direct impact on the quality of medicinal product and therefore patient safety. Regulation is imposed from a governmental level but is also employed in the form of comprehensive industry standards. The strive for regulatory compliancy is a direct cause for high overhead in software development projects, which leads to the procrastination of innovation. 14 interviews have been conducted with domain experts in a quest to understand and validate the difficulties of software development projects in the context of the pharmaceutical industry. The interviews focussed on the difficulties of software development projects in the pharmaceutical context and the lack of adoption of agile methods, as these have proven to reduce overhead of software development projects in other industries. The collected information is disclosed for the purpose of advancing the research area which is characterised to be minimally researched.