Warning Letter: Failure to indicate reason for change (ucm075728 )

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Ofni Systems

Failure to indicate the reason for change in automated data entries [21 CFR 58.130(e)]. In several instances, entries in the [redacted] collection/notes and audit trails failed to provide the reason for changing raw data. For example, audit trail entries for study [redacted]demonstrate that observations of “normal” were removed without an explanation.

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