This approach was never quite right. It spread validation resources thin, applied identical rigor to systems with vastly different impacts, and often resulted in thick binders that demonstrated compliance without ensuring quality. A sponsor might possess immaculate validation documentation for a system that captured exploratory biomarkers while the system holding pivotal safety data received the same—but no more—attention.

ICH E6(R3) offers a different path. The guideline does not abandon validation; it refines it. The question is no longer "Did we validate?" but "Did we validate appropriately for what this system does and the criticality of its data?"

This is the fit-for-purpose standard: validation effort proportionate to purpose.

This approach was never quite right. It spread validation resources thin, applied identical rigor to systems with vastly different impacts, and often resulted in thick binders that demonstrated compliance without ensuring quality. A sponsor might possess immaculate validation documentation for a system that captured exploratory biomarkers while the system holding pivotal safety data received the same—but no more—attention.

ICH E6(R3) offers a different path. The guideline does not abandon validation; it refines it. The question is no longer "Did we validate?" but "Did we validate appropriately for what this system does and the criticality of its data?"

This is the fit-for-purpose standard: validation effort proportionate to purpose.