Warning Letter: Failure to exercise appropriate controls on data (ucm369407)

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Ofni Systems

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

Your firm’s [redacted] “Jasco LC-Net II” HPLC instruments do not have restrictions in place to prevent any change or deletion of analytical raw data. Additionally, there is no audit trail in place to determine any previous deletion of raw data.

View the original warning letter.


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