FDA Spreadsheet Comments

 

Data Integrity App

FDA Spreadsheet Comments.

·         Nearly all of the spreadsheets in the laboratory showed rounding-off errors and none used the Excel rounding function, when needed to avoid rounding-off discrepancies between the original and check calculations by the second analyst.

·         Formulas in the analytical procedures did not follow the Excel equations.

·         Conversion factors were not expressed in the analytical procedures.

·         The formulas used by the check analyst for manual calculations were not the same as those used in the Excel spreadsheet validation.

·         The pre-determined specifications or limits were not shown in the spreadsheets.

·         Spreadsheets were not clearly documented. For example, the product declaration was not indicated, replaced by only a number in a cell.

·         Units were expressed as numbers without descriptive labels such as mg/mL or mg/g.

·         Sample weights were described as sample volume and areas as ratios.

·         Spreadsheets did not contain provisions for security and integrity of data.

·         Spreadsheet applications were not protected from changes, meaning analysts could freely change labels and formulas.

·         Regression analysis was calculated with the y and x axis inverted in the Excel formula, which generated erroneous slope and intercept results.



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