Date: 13 June 2012
Link FDA 483 (New Window)
Observation
5. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed in the release of drug products [21 C.F.R. 211.68 (a)]
For example, your firm did not verify the accuracy of Excel spreadsheets used to calculate product assay analytical results, for all products manufactured for
Monday, 30 July 2012
FDA Warning Letter - Microsoft Excel Spreadsheet
Posted on 04:58 by Unknown
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