CSA vs. CSV: Accelerating Validation by 400%

For years, Computer System Validation (CSV) has been synonymous with "Screenshots." Thousands of pages of documentation proving that a button is, in fact, a button.

The FDA's Pivot

With the draft guidance on Computer Software Assurance (CSA), the FDA acknowledged that the industry was spending more time documenting testing than actually testing.

The Core Difference

• CSV (Old Way): "If it's not documented, it didn't happen." Result: Bloated protocols, rigid scripts, fear of auditing.
• CSA (New Way): "Focus on high-risk features." Result: Critical thinking, exploratory testing, unscripted testing for low-risk areas.

Real-World ROI

We recently transitioned a mid-sized CRO from CSV to CSA for their new RBQM platform.

• Validation Timeline: Reduced from 6 months to 6 weeks.
• Documentation Pages: Reduced from 1,200 to 150.
• Bugs Found: Increased by 30% (because testers were actually looking for bugs, not just following a script).

CSA isn't cutting corners; it's cutting waste.