The Shift From CSV To CSA

In today's dynamic pharmaceutical landscape, adhering to regulatory guidelines and upholding high quality standards are critical imperatives. Traditional Computer System Validation (CSV) methods are increasingly seen as inadequate, often viewed as burdensome and time-consuming due to their standardized, one-size-fits-all approach to test script creation and execution.

With technology evolving rapidly, characterized by increased complexity and integration capabilities, the conventional CSV approach lacks efficiency. It has become more of a regulatory checkmark than a robust evaluation of technology suitability for its intended use.

There is a growing consensus on the need to transition from CSV to Computer System Assurance (CSA). This article highlights industry challenges, underscores the urgency of implementing CSA, and shares an approach to aid the pharmaceutical industry in understanding and embracing this essential shift.