Q: How do you maintain data integrity while migrating to electronic laboratory data recording?
Many laboratories are investing in digital solutions such as electronic lab notebooks (ELNs), laboratory information management system (LIMS), and connected instruments to support paperless workflows due to the many challenges posed by manual input and paper-based laboratory data recording.
Data integrity issues constituted 79 percent of all FDA warning letters in the past five years. The most common violations included:
- Not documenting all batch-related activities
- Backdating of data
- Not following procedures
- Transferring data incompletely
- Data captured on loose sheets of paper
- Samples not being labelled properly
- Missing or insufficient audit trail
A:Laboratory balances with sophisticated technical controls and integration into LIMS/ELNs make data integrity compliance easy.
The Cubis® II balance contains all the technical controls to support compliance without the need for additional software. All functions are integrated in the balance software and can be easily accessed within the balance touch screen. These technical control features include:
- User management
- Back Up
- Audit trail
- Time synchronisation
- Secure data transfer
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