The FDA’s new guidance on Computer Software Assurance or CSA (here) marks a shift—one that prioritizes critical thinking, product quality, and patient safety. In the world of regulated life sciences, the validation of software has long been guided by strict requirements. For decades, companies followed traditional Computer System Validation (CSV) approaches, often focusing on generating extensive documentation rather than assuring actual software quality and performance.

Question 1: So, what is CSA?

CSA is the FDA’s modern approach to validating software that supports “computers and automated data processing systems used as part of medical device production or the quality system.” Unlike traditional CSV, which often emphasizes exhaustive testing of every function regardless of risk, CSA encourages:

  • Risk-based thinking
  • Focused testing on critical functions
  • Efficient use of automation and unscripted testing
  • Streamlined documentation practices

In other words, it’s not about less testing—it’s about better, more focused testing.

Question 2: What has changed?

There has been a fundamental shift from “Test Everything” to “Test What Matters.” This will mean that companies should adopt a risk-based approach—identifying critical functions and focusing assurance efforts there. With any shift in regulatory guidance, myths and misunderstandings abound. Let’s tackle a few common misconceptions:

Myth 1: “CSA means less validation.”

Truth: CSA doesn’t reduce validation—it improves its focus. It still requires robust evidence that systems work as intended.

Myth 2: “Scripted testing is no longer needed.”

Truth: Scripted testing still plays a role. This is especially important for high-risk functions. CSA simply allows unscripted or exploratory testing when risk is low.

Myth 3: “We don’t need documentation anymore.”

Truth: Documentation is still required but CSA allows flexibility in how it is generated. Screenshots, logs, or summaries may suffice for low-risk tests.

Myth 4: “The FDA won’t accept CSA.”

Truth: The FDA created and promotes CSA. It aligns with the Agency’s push for innovation and patient safety without unnecessary regulatory burden.

CSA is more than just new guidance—it’s a mindset shift. It aligns regulatory compliance with modern software practices, focusing on what matters most—quality, performance, and patient safety.

Are you ready to embrace it? CSA offers a way to modernize validation programs, reduce inefficiencies, and foster innovation while staying compliant with FDA expectations.

The path forward may require facilitated change management . Lachman Consultants is here to help guide you through this change. Send us an email at LCS@LachmanConsultants.com to schedule a consultation on this important issue.