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    ALCOA+

    Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    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.

    What this means in practice

    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.

    Cross-references

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·1ICH·1ISO·1
    1. 1
      FDA Data Integrity Guidance
      Verified
      FDAfda.gov
    2. 2
      ICH Guidelines
      Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.