FDA Warning Letters
FDA Warnings and FDA 483s for Excel Spreadsheets
…your firm failed to have adequate procedures for the use of computerized systems used in the QC laboratory….. The investigator noticed that the current QC computer users are able to delete data acquired. In addition, the investigator found that there is no audit trail or trace in the operating system to document deletions. Additionally the investigator noticed that the use of the Excel spreadsheets in analytical calculations are neither controlled nor protected from modifications or deletion. The investigator noticed that the calculation ……uses an Excel spreadsheet that has not been qualified. We are concerned about the data generated by your QC laboratory from non-qualified and uncontrolled Excel spreadsheets.
….You stored original data in an “unofficial” and uncontrolled electronic spreadsheet on a shared computer network drive. Your analyst stated that original data was first recorded in this “unofficial” spreadsheet and transcribed later to an “official” form….
…..you used unprotected Excel worksheets to perform calculations and statistical evaluations of production data, such as standard deviation and process capability. These electronic files were not secured to prevent unauthorized changes, and have no change history…..