CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See

Description

Modern life-sciences teams are under increasing pressure to deliver systems that work, withstand scrutiny, and don’t drown projects in unnecessary documentation. That’s exactly where Computer Software Assurance (CSA) changes the game — and where most companies still get it wrong. This 90-minute session breaks through the noise and shows you how to build evidence the FDA actually wants to see, not the paperwork we’ve been conditioned to generate. You’ll understand how intended use drives everything, where traditional CSV thinking quietly sabotages speed, and how CSA gives you the freedom to focus on what truly matters: proving your system is fit for its purpose with confidence and clarity.

Across the industry, teams know CSA in theory — but struggle the moment they try to apply it. “How much testing is enough?”, “What does a real risk assessment look like?”, “How do we write requirements that support assurance instead of slowing…