Spreadsheet Audit Trails

COMPUTER SYSTEM VALIDATION (CSV) COMPLIANCE SOFTWARE
1

Hi all,

Just have a question on the audit trail side of things. We work within a cGXP environment. Use validated spreadsheets daily for calculation/reporting purposes.

The validated sheets are in a read-only directory (all clac’s etc fully locked, so they are only used for data entry), are opened data entered into them and then saved-as into a specific directory (also sent to NuGenesis).

Do we have to show an audit trail for all data entry changes made to the sheet? If so, is this possible without the addition of third party software?

2

If these spreadsheets (electronic records) are the official system of record (as opposed to printing and signing) then yes, you should have an audit trail of data entry changes (after intitial entries were entered and “committed” (saved).

The audit trail should document who made the change, from what to what, date/time change was made, and reason for change.

Our company utilized an e-infotree solution.