Common Challenges in Data Integrity
1. Deletion of Audit Trails
During recent qualification efforts for a depth filtration skid from vendor, we discovered that the system allowed deletion of audit trails. This is critical concern as trails are essential maintaining transparency and traceability in data handling.
2. Accuracy of Results
The Balances raised another issue, allowing users to alter decimal places and units. Such flexibility, while beneficial in some contexts, can lead inaccuracies that jeopardize product quality.
3. Attributability Issues
A protocol execution for the Multidose System revealed missing files due to user deletions. Alarmingly, audit trail did not attribute these actions any specific user, highlighting a significant gap in accountability.
We look forward to hearing about you. Please get started by emailing us at sales@biotech.com or using our contact form.
Download our White Paper today!
Fields marked with an * are required
