When regulators arrive, having a compliant spreadsheet is very important.
Excel spreadsheets need to manage Quality Control test data that have updated regulatory guidelines.
With non-validated spreadsheets, there are some regulatory concerns, these include:
- Lack of an audit trail
- No electronic signatures
- Password protection that is limited
- An absence of user security, this could conclude in anyone being able to change data when they may not have the training to
When reviewing quality systems compare data integrity with risk assessment guidelines.