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when we consider validating a computer system what comes to your mind tons of documentation cumbersome tedious time consuming challenging maybe non-value added and if some of these words come to your mind and some of these words are true for your organization youre not alone the fda is most interested in situations that could directly impact product safety or quality high risk events a long time ago the world of standards has moved towards risk-based approach in todays webinar tara will explain how to implement a sound risk management program while validating a computer system how one of the main parameters to implement a sound risk management program is to have a good understanding of the organizations critical data assets and how organizations would be in a better position to allocate their resources based on the criticality of the processes and the systems generating critical data sets and of course finally how only a risk-based approach leads to the best results and compliance
