Validation requirements for Excel file

Hi Guys

You may be able to give me some advice in relation to validation an excel file we use to trending and analysis of data.

We have a rather large file in which a variety of quality data is entered in order to make it easier to review for trends on a monthly basis. A sample of the data we track is Yields, NCMR rates, calibration metrics etc.Excel functionality is used to calculate various metrics such as % lots non conforming. For this calculation we enter in the number of batches manufactured and the # of NCMR’s generated. A simple excel calculation gives us the % and plots it on a chart.

While we have a paper based NCMR system we require all NCMR’s to be logged into this file so we now have a NCMR database of sorts where we can trend by category types (using pivot tables). All worksheets, formulas, cell formatting are protected. Even pivot tables cannot be manually refreshed. There is 1 macro that is run which unprotects all worksheets, refreshes all pivot tables and then reapplies the protection.

In summary, most of the data is this file is used for our management reviews to show increases or decreases in trends, rates, occurrence etc. None of the data in the file is used for the manufacture, release or design of product.

I have done some verification testing to make sure formulas are correct, protection is in place etc but the question that I am been asked now is do these files need to be part 11 compliant. Should it have audit trails, defined users access and password. I agree there are risks with the file in that data can be deleted, changed or duplicated, but other than going down the route of a add-in package there is not much more I can do reduce the risks.

Any input is greatly appreciated

Its great idea to validation of the exel file because whenever you get some thing new requirement at that time you have to add new things and modify that way when you are doing validation at that time it will appear how much system will operate.

If, as you say, “None of the data in the file is used for the manufacture, release or design of product”, it isn’t subject to FDA audit and therefore doesn’t require to be compliant with Part 11.