ALCOA+ is the data integrity framework regulators apply to clinical, manufacturing, and quality records. The '+' adds Complete, Consistent, Enduring, and Available to the original ALCOA principles. ALCOA stands for Attributable, Legible, Contemporaneous, Original and Accurate. Regulators including FDA, the MHRA and the WHO use these principles in data integrity guidance, and they apply to paper and electronic records alike. For electronic systems, the principles connect to 21 CFR Part 11 controls such as audit trails, access controls and validated systems.

Why it matters

Common in 21 CFR Part 11, EU Annex 11, and ISO 14155 audits. EHR exports, eCRF audit trails, and manual transcription practices are common ALCOA+ findings.

Common pitfalls

•Failing to implement robust access controls can compromise the "Attributable" principle of ALCOA+.
•Inadequate validation of electronic systems can lead to data integrity issues, particularly concerning the "Accurate" and "Consistent" principles.
•Not maintaining comprehensive audit trails makes it difficult to prove data integrity over time, violating the "Complete" and "Enduring" principles.
•Assuming that commercial off-the-shelf software inherently meets ALCOA+ without proper configuration and validation is a common mistake.

Sources

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.