Problems Using MS Excel Track Changes as an Audit Trail

MS Excel does have the ability to track some changes in spreadsheet data, but the Track Changes feature is not an 21 CFR Compliant Audit Trail, and Microsoft has never claimed that their Track Changes feature is compliant with 21 CFR 11.

For example, create a new spreadsheet. Put some data, “ABC” for example, in a selected cell.

These two screen shots were taken of the same cell a moments apart, after changing the User Name in Excel and the local date/time. (In Excel 2007, User Name is located under Popular Excel Options. In older versions of Excel, this is located at Tools  =>  Options =>  General.)

Again, this screen shot was taken of the same cell in the same spreadsheet a few minutes later in real time. With very little effort, the audit trail can be completely compromised, changing the original data value, the user making the change, and the time the change was made.

There are other issues with using the Track Changes feature as an Audit Trail:

• Track Changes does not prevent previous audit trail entries from obscuring previously entered information, as required by 21 CFR 11.10(e).
• Track Changes does not track changes all changes within a spreadsheet, including changes to sheet names or when a worksheet is inserted or deleted.
• Track Changes does not include a reason why data was changed.
• Track Changes can be deleted by saving the spreadsheet without personal information.

MS Excel can be made compliant with 21 CFR 11 and you can validate spreadsheets, but it requires additional tools, not present in MS Excel, to provide MS Excel with true Audit Trails,  Electronic Signatures, and Password Protection required by 21 CFR 11. Contact us for a demonstration and free 30-day trial.