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Views: 0 Author: Site Editor Publish Time: 2025-03-20 Origin: Site
Data integrity is not about being error-free — it is about being trusted.
Across the past decade, data integrity has become the defining topic for our regulators. Whether you read an FDA warning letter or an NMPA inspection notice, "data integrity deficiencies" sit at the top of the findings list. This article unpacks the ALCOA+ framework.
ALCOA+ is the foundational framework for data integrity. Originally articulated by the FDA and now adopted by regulators worldwide, it defines nine attributes of compliant data:
A — Attributable — every record can be traced to a specific operator and timestamp.
L — Legible — data remains readable throughout its lifecycle.
C — Contemporaneous — records are captured at the time the activity occurs.
O — Original — the original record is preserved, not only derived reports.
A — Accurate — the data faithfully represents the event.
+ — Complete, Consistent, Enduring and Available.
From our compliance consulting work, the most common ALCOA+ findings in monitoring programmes are:
Clock drift causing records and activities to disagree on when things happened.
Raw data overwritten, with only PDF or Excel reports surviving.
Shared user accounts across multiple operators.
Audit logs that can be turned off or cleared manually.
To make ALCOA+ truly operational, focus on five levers:
Systems — choose monitoring devices that natively support ALCOA+.
Processes — publish a Data Integrity Management Procedure.
People — regular ALCOA+ training and competency assessment.
Audit — at least one internal audit and one third-party audit per year.
Tools — automated audit trails and archival on the monitoring platform.
AQAC systems natively support all nine ALCOA+ attributes and are backed by a three-in-one compliance service: gap analysis, remediation consulting and training certification.
