This flow chart describes a process of the initial Risk-based Monitoring (RBM) implementation in a pharmaceutical company. It guides a reader through the first steps of decision taking. It involves such roles as senior management, RBM implementation team, process description team and an RBM application selection team.
This flow chart is the second step in a Risk-based Monitoring implementation when an RBM vendor needs to be selected.
This flow chart describes a more details steps in adaptive monitoring, centralized monitoring, and risk management steps. It applies the guidelines of ICH GCP and TransCelerate’s RBM.