Excel and Audit Trails

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Hi,

I have a query regarding excel and audit trails.

When using excel to store electronic records what are you using for audit trail - are you using a system like DACS with excel which provides additional security and audit trails? Are you using a macro with excel or how are changes to the records being tracked?

Any input would be most welcome.

Thanks,

Ray

2

We’re a partner with:

Our Excel Complete product uses this technology.
BTW the FDA also use this product.

3

Excel has an audit trail built in called Track Changes. It provides the date, time, old value, new value, and person. When you turn it on with a password it is not modifiable. The spreadsheet will even track multiple users at exactly the same time. It is great! There are many webinars that cover this feature along with all the other Part 11 features that are needed in FDA compliant spreadsheet application.

4

Hi dnettleton,
Pls indicate or provide tips , How to activate this Audit Trail feature in Excel sheet?

5

When you go to Excel (2007 and later), go to the top menu, then go to the “Review” Tab - and click on “Track changes.” When the “Track Changes” dialogue box pops open, make sure to check on all the tracking features you need. Once you are done there, go back to the top menu, click the “Review” Tab, and then click on “Protect Shared Book.”

This feature will enable you to satisfy some of the compliance requirement, but you will still need to validate the spreadsheets.