Blog tagged as software validation

The FDA’s shift from Computer System Validation (CSV) to Computer Software Assurance (CSA) is often described as a move from “test everything” to “test what matters.”  

For clinical laboratories and blood banks, that is both liberating and unsettling. We work in environments where patient s...

Healthcare systems are under intense pressure—staffing shortages, tighter budgets, rising operational demands—all while navigating the relentless pace of digital transformation.