Open AccessApplication validation versus infrastructure qualification
Author(s) -
Hulleman R.
Publication year - 2013
Publication title -
isbt science series
Language(s) - English
Resource type - Journals
eISSN - 1751-2824
pISSN - 1751-2816
DOI - 10.1111/voxs.12016
Subject(s) - computer science , audit , process (computing) , black box , critical infrastructure , quality (philosophy) , risk analysis (engineering) , computer security , business , operating system , accounting , philosophy , epistemology , artificial intelligence
An often used method for application validation is the “black box” approach. The functionality or application is tested against predefined protocols and the results are compared to also predefined expected results. The underlying infrastructure is automatically validated in combination with the application. Audit Authorities and GMP regulations (Annex 11, GAMP) ask for a Qualified Infrastructure nowadays. An IT infrastructure is a complex system of IT components working together to enable the user to “use the applications” that run on it. To qualify an infrastructure the infrastructure has to be split up in parts; the “infrastructure components”. The process of building and changing these components has to follow strict Quality requirements.