Requirements Engineering in the bio medical industry: GAMP 5 and tooling
Gauthier Fanmuy, Richard Szczepaniak · INCOSE International Symposium · 2010
Abstract The principles of systems engineering are applicable to all types of systems including computerized systems. They are particularly effective for these systems because the computer is still new technology, they can better understand the development and life cycle of these systems by erasing the image of “black boxes”. It is now essential for computer systems to carry more and more critical actions especially in highly regulated industries such as pharmaceuticals or medical devices industries. These industries has established a repository, the GAMP (see reference [1]), in order to define the correct principles to be established for computerized systems. This paper presents the principles of systems engineering defined in GAMP and how they were developed by the company ADN and CORTIM for the pharmaceutical and medical devices industries.