Ms Excel Book Validation
Spreadsheet validation is an opportunity to add value to the computerized system.
It ensures that system data is controlled and protected.
The validation applies to all forms of computerized systems used as part of GxP-regulated activities. Therefore, if spreadsheets are used to manage regulated information, operation and security must be ensured according to the intended use determined through a validation project.
- Details of the spreadsheets to be validated: an inventory of Excel sheets to be evaluated, risk analysis (from the point of view of intervention in the process, impact on product quality or data integrity or traceability) and classification according to GAMP5.
- User requirements to define the intended use at functional, safety and data integrity level.
- Qualification of its installation, use, and process.
- Maintenance of its control status throughout the life cycle.
To be able to evidence in a documented way the correct operation and data integrity of the Excel sheets in the GxP process.