A Hidden Barrier to CSA Implementation: Why Digital Validation Is the Missing Link
From Ideas to Practice: Enabling Risk-Based Validation Through Digital Infrastructure
The FDA's Computer Software Assurance (CSA) guidance, released in 2022, introduced a welcome shift in validation strategy: risk-based, right-sized assurance that prioritizes fitness for intended use over exhaustive documentation.
But two years later, most life sciences organizations still struggle to realize its benefits. The promise of faster, smarter, …