Warning Letter: Spreadsheet data entry cells not locked (ucm229262)

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Ofni Systems

We observed 8 of 9 worksheets where one or more tabs with formula cells were not locked. These worksheets were used for analyzing raw data from drug component and product samples, including [redacted]. Your firm’s SOP 100-G-0110, “Creation and Use of Templates,” stated that cells, in which data is entered, must be locked within their electronic template.

View the original warning letter.


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