WARN 11/14/96 Digisonics
1. Failure to establish and implement adequate quality assurance procedures that provide detailed descriptions of the procedures to be used to perform regression testing after changes to the software have occurred [21 CFR 820.100(a)(2)].
We acknowledge your response to the FDA-483 dated July 10, 1996. The information in your response is inadequate because it fails to provide sufficient detail of the validation necessary to ensure the device performs as intended. For example, the “Final Device Inspection: Gynelogic Program,” is limited input-output testing. There is no assurance the program will operate as intended in the environment or under conditions it was designed. Similarly, the “Operating Procedure for Methodology to Be Used When Performing Regression Testing, June 28, 1996,” fails to include all external influences that may impact on the performance of the device. Your procedure is designed only for unit or module testing and does not ensure full integration of the software changes with the existing code.