The method

In an industry where the focus on quality is key, software developments tend to suffer from the significant overhead that comes with governing quality. In the meanwhile, agile software development methods are gaining cross-industry traction as the preferred software development method.

Method æ has been created in an attempt to pivot the highly documentative nature of software development projects in the specific domain of the pharmaceutical industry. This is done by using best practices regarding to procedural method engineering, regulatory mandatory project-elements (GMP Annex 11 'Computerised Systems', FDA CFR Part 11 'Electronic records; Electronic Signatures'), industry standards (ISPE's GAMP5 and PIC/S), and input from various experts from the pharmaceutical industry (validation, quality assurance, software development, top-management and more).

Method æ and the related research artifacts have been presented at the 14th International Conference on Computational Science and Its Applications (ICCSA2014) in Guimaraes, Portugal, and the 6th International Conference on Software Technology and Engineering (ICSTE2014) in Paris, France.

"Always go to the source code; it cannot lie, as documents can"

- James Grenning (2001)

The papers

If you are interested, we would suggest you to read the papers in chronological order. For immediate details about the method, we suggest you to skip the first two papers and directly go for the last one.

1st paper

"How the Pharmaceutical Industry and Agile Software Development Methods Conflict"

  • Presented at ICCSA2014, Guimaraes, Portugal
  • 816-401-3913
  • pp. 40-48

3rd paper

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

The authors


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