Soring Germany 8/9/96 ultrasonic dissection/aspiration devices
2. Failure to establish and implement specification control measures to assure that the design basis for the device is correctly translated into approved specifications, as required by 21 CFR 820.100(a)(1). For example, there is no documented software validation for the software which operates all devices manufactured by your firm.
Your response is not adequate. The investigator was assured that software used in all devices was fully tested and validated; however, no one took the time to document the procedures. The response included a test procedure entitled “Test Record for Software” to be used in the testing and validation of your software. No data was submitted showing that the validation has occurred. The investigator was told that the validation would be complete by 08/01/96. All validation data should be submitted to the FDA as soon as the studies are completed.
3. Failure to have specification changes approved and documented by a designated individual(s), including an approval date and the date the change became effective, as required by 21 CFR 820.100(a)(2). For example, there is no documented software validation for changes made in the software which operates all devices manufactured at your facility.
Since this was not listed on the FDA-483 you could not respond. However, you did respond to not having your software validated, FDA-483 item 1. The “Test Record for Software,” enclosed with your response, does not address re-validation of software if changes are made. All testing and validation of software should be documented, and the software should be re-validated following any changes.
O6. Failure to validate software programs by adequate and documented testing, when computers are used as part of a quality assurance system, and failure to routinely calibrate all quality assurance measurement equipment, as required by 21 CFR 820.61. For example:
a. There is no software validation for the two computer systems, [purged text], which conduct the final system testing for all units.
