Software development projects in the context of the pharmaceutical industry are highly restricted. Innovation in terms of process changes within the practice of software development has to manoeuvre though the regulatory wilderness of legislation and industry standards. 49 articles have been selected using the Systematic Literature Review method to evaluate the maturity of this field of research. Agile methods conflict with the generally accepted software development methods within the pharmaceutical industry. Even the acquired set of literature disseminate about a various amount of topics regarding to the conflict of agile methods and the pharmaceutical industry. This research concludes that the appliance of existing agile methods in the pharmaceutical industry is relatively non-existent, possibly causing software development projects to exceed budgets.

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Abstract-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. IndexTerms-Agile pharmaceutical industry, problem-centered interviewing, regulatory compliance, software development.