[FONT=Arial][SIZE=3]Does a spreadsheet sheet need to be validated ?
if the spreadsheet is saved, then this is an electronic record and part 11 applies. in this case the spreadsheet isn’t saved; therefore, part 11 doesn’t apply.
validation of the spreadsheet is a business decision. in my experience, you don’t need to validate spreadsheets if you don’t mind checking each calculation every single time. so in essence, you’re validating the spreadsheet each time which is a waste of time. so it’s easier to validate the ‘master’ spreadsheet, keep it in control, and prove that any results generated were generated using this ‘master’ validated spreadsheet (part 11 applies to this ‘master’ spreadsheet). if the paper record is official, then you need process and controls to ensure who’s generating the paper record, and still need to verify whoever printed the spreadsheet entered the inputs correctly into the spreadsheet since that’s still a manual process.
for this situation, each processing using a master template spreadsheet is discarded because the printout is the official record, and the electronic version is never saved…but you’re relying on some assumptions: 1. the master spreadsheet is validated 2. the master spreadsheet is controlled 3. you have proof that the user used this master spreadsheet to generate the results and didn’t do something on their own.