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General Information
    • ISSN: 2301-3559
    • Frequency: Quarterly
    • DOI: 10.18178/LNSE
    • Editor-in-Chief: Prof. Jemal Antidze
    • Executive Editor: Ms. Nina Lee
    • Abstracting/ Indexing: EI (INSPEC, IET), Electronic Journals Library,  Ulrich's Periodicals Directory, International Computer Science Digital Library (ICSDL), ProQuest and Google Scholar.
    • E-mail: lnse@ejournal.net
Editor-in-chief
Prof. Jemal Antidze
I. Vekua Scientific Institute of Applied Mathematics
Tbilisi State University, Georgia
I'm happy to take on the position of editor in chief of LNSE. We encourage authors to submit papers concerning any branch of Software Engineering.

LNSE 2015 Vol.3(4): 251-262 ISSN: 2301-3559
DOI: 10.7763/LNSE.2015.V3.200

Method æ, the Agile Software Development Method Tailored for the Pharmaceutical Industry

A. Hajou, R. S. Batenburg, and S. Jansen
Abstract—Agile software development methods have a high adoption rate due to their proven business benefits. Its success has not yet been identified in the pharmaceutical industry, due to the industry’s incompatibility with generic agile methods. Comprehensive research has been done to engineer a tailored agile method driven by the needs of the industry. 14 interviews were conducted with domain experts to elaborate on problems they encountered during software development projects in the pharmaceutical industry. A total of 137 method requirements were extracted from the interviews to engineer an agile method tailored for the pharmaceutical industry. Method æ has planned and iterative phases, enforces risk oriented decision making and reduces the number of documents to an absolute minimum. Method evaluation proves that Method æ is inter alia compliant to the EU GMP Annex 11 regulation and can therefore serve as a substitute for software development projects in the pharmaceutical industry.

Index Terms—Agile, software development, pharmaceutical industry, regulatory compliance.

The authors are with the Department of Information and Computer Science at Utrecht University, the Netherlands (e-mail: a.hajou@students.uu.nl, r.s.batenburg@uu.nl, s.jansen@uu.nl).

[PDF]

Cite: A. Hajou, R. S. Batenburg, and S. Jansen, "Method æ, the Agile Software Development Method Tailored for the Pharmaceutical Industry," Lecture Notes on Software Engineering vol. 3, no. 4, pp. 251-262, 2015.

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