Data Integrity (ALCOA+)
Data integrity ensures monitoring data is accurate, complete, and reliable throughout its lifecycle, following the ALCOA+ framework.
What is Data Integrity (ALCOA+)?
Data integrity refers to the completeness, consistency, and accuracy of data throughout its lifecycle. In regulated industries, the ALCOA+ framework defines the requirements: data must be Attributable (to the person or system), Legible (readable and permanent), Contemporaneous (recorded at the time of activity), Original (or a certified copy), and Accurate (correct and truthful). The "+" adds: Complete, Consistent, Enduring, and Available.
For IoT monitoring systems, data integrity means that sensor readings are captured accurately, transmitted without corruption, stored securely, and cannot be retroactively modified without an audit trail.
Why It Matters
Data integrity failures are the #1 cause of FDA Warning Letters in recent years. If monitoring data cannot be trusted, all compliance claims built on that data are invalid. This can lead to product recalls, facility shutdowns, and criminal prosecution in severe cases.
Frequently Asked Questions
What does ALCOA stand for in data integrity?
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. The extended ALCOA+ adds Complete, Consistent, Enduring, and Available. These principles apply to all data in GxP-regulated environments.