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?