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...Read More

Diehl Inc. Food Processing 2/12/99 The chart recorder and the computer display on the xxxx units did not correspond to the mercury-in-glass (MIG) thermometer. The chart recorder or computer display may show a reading up to 3 degrees F higher than the MIG thermometer. SoftwareCPR keywords: Production software, validation, electronic recordsRead More