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
| Original language | English |
|---|---|
| Pages (from-to) | 251-262 |
| Number of pages | 12 |
| Journal | Lecture Notes on Software Engineering |
| Volume | 3 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Nov 2015 |
Keywords
- Agile
- Software Development
- Pharmaceutical Industry
- Regulatory Compliance