Warning Letter: Lack of Audit Trails and other deficient computerized system controls (ucm478393)

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Ofni Systems

“Your firm failed to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel (21 CFR 211. 68(b)).

You lacked audit trails or other sufficient controls to facilitate traceability of the individuals who access each of the programmable logic controller (PLC) levels or Man-Machine Interface (MMI) equipment. You had no way to verify that individuals have not changed, adjusted, or modified equipment operation parameters.”

View the original warning letter.


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