This white paper examines how FDA-regulated industries must evolve compliance practices for the digital era. Traditional computer system validation (CSV) is burdened by heavy documentation and limited focus on quality. The FDA’s Case for Quality and Digital Health Center of Excellence shift the emphasis toward risk-based, quality-driven approaches. The new Computer System Assurance (CSA) framework prioritizes patient safety, data integrity, and product quality over paperwork. CSA introduces scripted and unscripted testing to balance efficiency and risk. By adopting CSA, organizations can reduce validation effort by up to 80%, accelerate digital transformation, and align compliance with innovation.

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