McGHAN Medical Corporation 2/16/96 mammary prostheses

The validation of the computerized dip timer system for software version [purged word] and [purged word] fails to assure that the previous files are overwritten when the maximum number of files [purged word] is reached. This is demonstrated by the fact that there was no verification of the file contents and the files were created empty during the validation. Routine dipping production conditions generated actual data files. There is no way to assure that files containing actual data are completely overwritten when the maximum number of files is reached. This deficiency is related to test record #5 in document [purged word].
c. Computer software validation did not include security safeguards in the protocol procedure (SOP 9-015, Rev. C, dated May 3, 1994), for the “[purged word] Computer System Validation.”