Ensuring regulatory compliance and maintaining high-quality standards is fundamental in the pharmaceutical industry. However, the conventional approach of computer system validation (CSV) is proving to be insufficient for keeping up with the complex demands of the industry. It is frequently characterized as a burdensome task, with time-consuming and rigid validation exercises due to a standardized, “one-size-fits-all” approach to the creation and execution of test scripts.

With the ever-increasing complexity, integration capabilities, and faster pace of technological development, this burdensome approach is lacking efficiency and turning into a mandatory regulatory checkmark instead of the actual evaluation of the technology's fitness for its intended use.

The time has come for a significant shift from CSV to CSA, focusing on preventing the introduction of defects the software development process while applying a risk-based approach to determine the suitable level of assurance effort and activities to establish confidence in the software. Furthermore, CSA supports the maintenance of a state of control throughout the software development lifecycle. This paper aims to shed light on the industry's current challenges, highlight the pressing need for CSA implementation, and present an approach to assist the pharmaceutical sector in comprehending the necessity of CSA adoption.