Computer Software Assurance for Production and Quality System Software: Guidance for Industry and FDA Staff
The finalization of this guidance in 2025 marks an exciting step forward in the GxP Computer Software Assurance space.
In particular, Pg. 14 section (4) of the document, “Determining the Appropriate Assurance Activities” is interesting. It provides clarification on the type of testing that is required of classified risks; they must be tested commensurate with the device or process risk presented. As always, patient safety is paramount in this determination. Any patient interfacing systems are subject to increased risk and testing scrutiny. [1]
The two types of testing that are explicitly stated as accepted by FDA are Scripted and Unscripted testing. This means that unscripted testing is acceptable for certain risks, and these commonly fall into three categories: Scenario Testing, Error Guessing and Exploratory Testing. All of which may be powerful methods to catch errors prior to the system change being released into the Production environment. Scripted testing is a more detailed way that makes the possibility to repeat testing over time a simpler reality. [1]
It can’t be understated how important the quality of the validation resource is in performing the correct type of testing. An excellent validation resource may be able to identify most system issues simply through Error Guessing testing. The quality of testing as well as the associated knowledge transfer is essential to the end of project result.
Regardless of the type of testing that is decided upon, it’s the GxP Record that counts from a compliance point of view. These records should include: Intended Use, Result of risk-based analysis, Summary description of failure-modes tested and testing performed, Issues found, Conclusion declaring acceptability of the software for its intended use (including resolutions and justifications), Record of who performed testing, Review and Approvals. A Test Plan and full summary of Test Results may be necessary as well.[1]
Wishing you and your family a happy 2026!
[1] Computer Software Assurance for Production and Quality System Software: Guidance for Industry and FDA staff. September 24, 2025
