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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 the regulation says
    Regulators and standards bodies, such as the FDA (e.g., in their guidance on Data Integrity and Compliance with cGMP) and the EMA (through EU GMP Annex 11), emphasize ALCOA+ principles to ensure the trustworthiness and reliability of data. These principles are foundational for demonstrating compliance with quality system regulations, including those outlined in 21 CFR Part 11 for electronic records and electronic signatures, and for clinical trial data integrity as described in ISO 14155.

    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.

    Examples

    • A clinical trial site implements an electronic data capture system with audit trails that record every modification, demonstrating the "Attributable," "Contemporaneous," and "Enduring" aspects of ALCOA+.
    • A medical device manufacturer meticulously documents all calibration records for manufacturing equipment, ensuring the data is "Legible," "Original," and "Accurate" for regulatory audits.
    • During a software update for a diagnostic device, all historical patient data remains accessible and verifiable, fulfilling the "Available" and "Consistent" principles of ALCOA+.
    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.

    Frequently asked questions

    ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. These principles ensure data integrity throughout its lifecycle.

    Cross-references

    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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.