How the Pharmaceutical Industry and Agile Software Development Methods Conflict: A Systematic Literature Review

Abstract

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.

A case study of agile software development for safety-Critical systems projects

“…These customers may, in turn, be procuring the product as a component to be integrated into one or more larger systems for their own customers. This network of stakeholders is characteristic of safety-critical systems projects, and so "Agile use in these environments is restricted by the elements that define these environments" (Hajou et al, 2014). However, from the participant's perspective, the influence of external customers is difficult to manage, because they only have direct access to the systems team in order to demonstrate their work and receive feedback "For me, I would say that customer demonstration ... would be the demonstration of how things work when it gets to the TEST ENVIRONMENT (P2)."…”

A conceptual model of agile software development in a safety-critical context: A systematic literature review

“…Cawley et al (2010) concerns lean and agile software development in regulated environments, whereas (McHugh et al, 2012c) and (Hajou et al, 2014) focus on agile software development of the medical devices and in the pharmaceutical industry. While Hajou et al (2014) conclude that the two are incompatible, Cawley et al (2010) conclude that adoption of agile development in these areas is difficult and McHugh et al (2012c) argue that tailoring of the agile methods are needed and propose a mixed method. These conclusions do not reveal the challenges and possibilities of using agile software development of safety-critical products.…”

Scrum for safety: an agile methodology for safety-critical software systems

“…Indeed, some pioneering works concerning the adoption of agile methods in the safetycritical domain concluded, hastily, that the former and the latter are incompatible (Cawley et al, 2010;Hajou et al, 2014). Nevertheless, more recent results questioned this conclusion, identifying four main challenges inherently arising while adopting agile methods in the safety-critical context, i.e.…”