Stage 7: Decision Point: Fitness for Context of Use

In accordance with previous guidance from ASME and ICH (ASME, 2018; ICH Q1, Q2(R2), Q14), a structured decision should be made on whether the model has achieved sufficient credibility to be considered fit for its defined Context of Use. This is consistent with the principle that credibility is not absolute but context dependent. If the model is found not to fulfil the requirements of the Context of Use, additional development or validation activities are undertaken.