Nucletron Corporation 5/21/97 Brachytherapy products
b. Specific versions of Veriflex software are ordered, but no SOPs exist which require verification of the version received. Furthermore, the Purchase Order database, used to check incoming components against part numbers, lists obsolete software versions under the current part number.
3. Failure to follow complaint procedures and to maintain complete complaint files, as the files did not always contain required documentation or the reply to the complainant. For example, complaints involving errors in Veriflex software are fixed and reported to customers in technical bulletins for the next released version of the software. However, not all complaints resolved by a particular version of the software are reported to the customers in these technical bulletins. For example, complaint report 30-951200101 was corrected in Veriflex version 2.02, but was not reported to the customers in the technical bulletin for version 2.02.
4. Failed to maintain complete written failure investigation records, including records of the investigation, conclusions, and follow-up regarding Veriflex system software failures to meet performance specifications after the device had been released for distribution. For example, the “Test Plans” for the validation of Veriflex software corrections do not correspond to the “Test Cases” and complaint numbers in the “Test Reports.”
5. Failure to perform adequate finished product testing for Veriflex version 2.05, in that the software testing for this version did not fully test the software under simulated conditions of use. For example, the software testing to correct the software errors covered by Device Complaint Report #30-163, “Continuous log printing not printing wedge MU’s” covered only expected operational conditions. There was no testing of error conditions, negative testing, or boundary condition testing.