Warning Letter: Audit trail data for system is inconsistent with printed records (ucm560653)

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Ofni Systems

Your firm does not exercise appropriate controls over computer related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 C.F.R. 211.68(b)]. For example:

A. Your “Processed By” dates and times listed on printed chromatograms do not always show the same “Processed By” dates and times listed on the system chromatograms.

B. Your data in the audit trails does not always show the same data listed on your printed chromatograms.

Your response states you have not observed any test result data discrepancies between your printed versions of the test results. However, this does not address adequate electronic data controls to prevent inconsistencies between the printed and electronic data. Your responses for 2A and 2B above are not adequate in that your firm did not provide any corrective action addressing the assessment of all relevant data in the audit trails.

C. Your firm enters data into [redacted] files to complete plate assay calculations but they are not locked from editing once the file has been reviewed.

Your response fails to include any corrective action to ensure that there is no further access or ability to save over test results in [redacted] spreadsheets once reviewed and approved.

D. Your firm did not give unique sample set names to different sequences of samples run on different instruments on the same day.

Your response is not adequate. Your firm did not address the concern of the possibility of sample sets with the same name overwriting each other during the data backup process…

Your procedure is to then enter the raw data into document number MIC-0066-13-01 titled “[redacted]”, Attachment 1. On the completed form, the [redacted] test results for the [redacted] zones were not the same as observed by our Investigator; the range was 11.4 to 15.1. Your firm used an Excel spreadsheet to calculate the potencies of Tri-Otic Ointment lots H610 and H6514 as [redacted] and [redacted], respectively.

Your response does not provide documentation of the January 26, 2017 handwritten zone diameter results for Tri-Otic Ointment (Lots H6510 and H6514), which you allege differ from our investigators’ direct observation. We note your response acknowledges that you should have provided our Investigator a copy of the handwritten zone diameter results. You have not subsequently verified complete raw data was maintained.

View the original warning letter.


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