See what a validation package looks like when it builds itself
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demoComputer Software Assurance, CSA, is FDA guidance that pushes validation effort toward risk based, critical thinking testing instead of scripting every function regardless of how minor it is. It does not remove the need for evidence. It changes how much evidence a given system actually needs.
Under the older, heavily scripted approach, a team would write a detailed test script for nearly every function, execute it step by step, and file a screenshot for each step, whether the function was safety critical or cosmetic. CSA asks teams to reserve that level of rigor for the features where a failure would actually matter, and use lighter, unscripted testing for the rest.
Some vendors market CSA as a reason to skip documentation altogether, which is a misreading. The guidance still expects a documented rationale for why a given test approach was chosen and evidence that the testing happened. What changes is the format and depth, not whether evidence exists at all.
Ask whether the vendor's testing approach distinguishes between high risk and low risk functionality, or whether every feature gets the same treatment by default. A platform that cannot show that distinction has not actually adopted CSA thinking, whatever the marketing page says.
No. Part 11 covers electronic records and signatures. CSA is guidance about how much and what kind of testing effort a system's features need. The two operate on different layers of the same validation problem.
FDA has been developing CSA guidance over several release cycles. Check FDA's own site for the current status before citing a specific version in an audit response, since guidance documents move through draft and final stages on their own timeline.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demo