Here’s this week’s example of an Additional Information Request (AI Request):
FDA Additional Information Request – Example #8: Missing Version of a Test Referenced in a Report
The XYZ Software Test Report, test case A, Version testing, seems to indicate that V.1.1.1 was tested. It is not clear why this version was used in this test case, as the version under test was noted to be V1.1.3. Please clarify this discrepancy and provide updated testing for the most current version of software.
In this example, the FDA’s Additional Information Request focuses specifically on a single test procedure log, part of the Software System Test suite.
This is a classic example of failure to keep tight configuration management of the application’s versions over time. The FDA detected a discrepancy between the final Test Report (which identifies V1.1.1 as the target version) and one of the Test Cases, which recorded the application’s V1.1.3 as the application target version.
The Test Report may incorrectly report V1.1.1 as the target, which may be as simple as updating the version mentioned in the Test Report. It may also require performing a regression analysis to determine whether re-execution of other Test Cases on application version 1.1.3 is required.
Or it could be the Test Case incorrectly recorded V1.1.3. Correcting the error would require re-execution of the Test Case on application V1.1.1 and recording this version in the log.
In either case, a new version of the Test Report must be generated referencing the correct and consistent application version.
If any other discrepancies in configuration management are found in the testing, we recommend re-execution of ALL software testing on the correct application version, resulting in test case logs which correctly identify a single “correct” application.
A regression analysis may be used to justify why some older test logs, run on earlier application versions, are still appropriate and correct. An example of a rational would that whole area of the source code wasn’t changed from V1.1.1 to V1.1.3, therefore re-executing the test would not yield any changes.
After correcting the challenge, FDA asks to be provided with updated testing executed on the most current version of the software application. For consistency, the most current version of the software should be the software version being submitted for consideration.
Please follow us to see more examples of AI Requests – a new one is released every week.
Should you receive an Additional Information Request from the FDA, CriTech is here to help. Please give us a call to discuss and we’ll help you craft what you need to do going forward.