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OSP software validation - what and how? #106
at the moment we are internally discussing the software installation/performance validation of the OSP suite. Does someone have experience in what exactly and how one has to validate the OSP software to comply with regulatory requirements? Additional question: Where can I find these regulatory requirements? (and do they give any instructions on how to comply with them?)
Many thanks in advance!
This ensures that all tested features produce on the system of the end user the same results as in the OSP Suite (since the features were implemented and tested for the first time)
With this procedure e.g. the installation validation from the EMA guideline “Qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation” is fulfilled.