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Excel Sheet Validation

Why do we validate Excel spreadsheets?

There are multiple reasons:

  • Excel spreadsheets may be used to automate calculations, which in turn have to be validated because you need to be sure that your calculations are correct.

  • They may contain critical data like test results.

  • A completed spreadsheet is considered an electronic record and must as such be Annex 11 and CFR 21 Part 11 compliant.

  • Excel AND Excel spreadsheets are considered to be software according to GAMP5, which can immediately be used to assist during validation.


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