Warning Letter: Failure to exercise appropriate controls over computer systems (ucm545133)

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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)).

Our investigators observed that information technology (IT) staff at your facility share usernames and passwords to access your electronic storage system for [redacted] data. Your IT staff can delete or change directories and files without identifying individuals making changes.  After a previous inspection in which FDA observed similar deficiencies, you committed to eliminate these and other data integrity vulnerabilities.

In response to this letter:

Provide your detailed plan to ensure that each current and future employee will have a unique username and password to allow tractability of changes to electronic data back to specific authorized personnel.

Describe the specific changes made to your software and electronic systems to ensure the effectiveness of your corrective actions.

View the original warning letter.


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