Continued regulatory focus on data integrity
Data integrity is driving changes in global compliance. Audits by the FDA and other regulators continue to identify fundamental data integrity issues. These findings drive the sustained regulatory focus on the data integrity across the laboratory, including instrument qualification. Many data integrity failures can be traced to weak governance. Laboratories that use PDF forms, Excel, or paper-based protocols for qualification are reliant on procedural controls for data integrity. This is a fundamental weakness.
