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  • Warning Letter: Failure to Validate MS Excel Spreadsheets (s6366c)

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    Ofni Systems

    Failure to adequately validate the intended use of this PC and its software, as required by 21 CFR 820.70(i). “For example: the dedicated PC [redacted] attached to the [redacted] was not secure in that access to the data on [redacted] was not granted by a unique username and password or equivalent method; there as no documentation associated with the electronic data for whom was responsible for collection of the analytical results as several quality control personnel have access to the [redacted] no software changes in the study data could be detected as there was no audit trail capability ; and finally, the electronic data did not correlate with the paper records.”

    View the original warning letter.


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