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In a previous article, we looked at the reasoning behind why the FDA thought there was a need for a change of approach for many companies with their Computer System Validation (CSV). In this article we will look at how a more structured risk assessment approach will lead to greater computerised system rewards – and at a lower cost.

Computerised System Validation (CSV) is an activity carried out by Pharmaceutical and Medical Device organisations to ensure that IT infrastructure and applications that impact product quality are operating in a controlled state. Organisations must demonstrate an appropriate level of control of their Computer Systems to regulators such as the US...