Inadequate process validation; failure to validate the test methods used to analyze raw materials and the finished product; failure to institute process qualification for the laboratory instruments used to perform in-process and finished product testing; failure to qualify or validate the firm’s computer software programs; and failure to perform investigations into out-of-specification weight and diameter test results.
4. The firm’s computer software programs (_____), which operate all of the laboratory equipment during the analysis of raw materials and Syncro-Mate B Implant finished product, have not been qualified and/or validated. The software programs do not secure files from accidental alteration or losses of data. The functions that modify and delete partial or whole data files are available for use by all analysts. In addition, the firm has not established any security procedures for the laboratory computer systems. There are no procedures for backing up data files and no levels of security access established.
