Warning Letter: Uncontrolled Excel spreadsheets (ucm369409)

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Ofni Systems

For example, your firm failed to have adequate procedures for the use of computerized systems used in the QC laboratory. At the time of the inspections, your QC laboratory personnel shared the same username and password for the operating systems and analytical software on each workstation in the QC laboratory. In addition, no computer lock mechanism had been configured to prevent unauthorized access to the operating system. The investigator noticed that the current QC computer users are able to delete data acquired. In addition, the investigator found that there is no audit trail or trace in the operating system to document deletions.

Additionally, at the Aarti Drug Limited facility (FEI 3009688205), the investigator noticed that the use of the Excel® spreadsheets in analytical calculations are neither controlled nor protected from modifications or deletion. The investigator noticed that the calculation for residual solvent for [redacted] uses an Excel spreadsheet that has not been qualified. We are concerned about the data generated by your QC laboratory from non-qualified and uncontrolled Excel spreadsheets.

View the original warning letter.


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