ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate. The ALCOA+ extension adds Complete, Consistent, Enduring and Available.
Why it matters
Regulators such as the FDA, EMA and PIC/S treat data integrity as central during inspections. A gap in the Audit Trail or e-Signature can lead to a serious observation.
Applying it
When designing EMS/MES systems, ensure every record is tied to an operator (Attributable), time-stamped in real time (Contemporaneous), stored as the original (Original) and cannot be silently altered (a complete Audit Trail).
The core principle: Data Integrity by design — build controls into the architecture and access model rather than patching after go-live.