I’ve been seeing many posts on LinkedIn pushing the idea that:

"Companies must transition” from CSV to CSA"

This often implies that CSA is simply about going paperless.

This narrative misses the point.

If CSA suddenly feels like a revolution, it may simply mean validation strategies have been executed too mechanically.

We’ve all seen it:

▪️ One-size-fits-all validation

▪️ Risk Assessments exceeding 90 pages (something I’ve personally witnessed)

▪️ Documentation bloat with little added value

None of that was ever required by regulation. Let’s be clear:

▪️ CSA is not replacing CSV

▪️ CSA is not about going digital

▪️ CSV never required documentation overload

CSA doesn’t remove CSV; it elevates it with:

▪️Critical thinking

▪️ Foreseeable risk focus

▪️ Value-based evidence

▪️ Expertise-driven testing

The difference today is that the FDA has made this mindset more explicit to help harmonize approaches across the industry.

And here’s the key:

You don’t become a critical thinker just by reading the CSA guidance.

That ability is developed over time through understanding:

• The why behind each activity
• Business processes
• Data flows and vulnerabilities
• Intended use and risk exposure

Also, CSA has nothing to do with going fully digital. You can apply CSA principles even in a paper-based environment. It’s not about the medium; it’s about the thinking.

So, what’s new within CSA?

• Supplementing the General Principles of Software Validation (GPSV), replacing only Section 6
• Introducing terminology aligned with today’s tech (SaaS, PaaS, IaaS)
• Shifting to foreseeable risks rather than blanket requirement-based assessments
• Leveraging tester expertise and system familiarity
• Encouraging flexible, discovery-driven testing approaches

As a final note, consultants and validation SMEs have a responsibility to:

• Guide clients with clarity
• Challenge misconceptions
• Build trust 🤝
• Avoid outdated paradigms

Want to go deeper?

I’ll be delivering a Computer Software Validation course on:

🗓️ December 2, 9, and 23, 2025

Event link: https://lnkd.in/dfjd5Qdp

We’ll break down how CSV and CSA complement each other, and how to build critical thinking into validation practices regardless of your tools. That’s what makes our course unique.