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Data IntegrityALCOA+GxP

ALCOA+ Data Integrity Principles Explained

Anxya Health · September 1, 2026

What is ALCOA+?

ALCOA+ is a set of principles that define trustworthy data in regulated environments. Data-integrity failures are among the most common and costly regulatory findings.

The principles

  • Attributable — who created or changed the data, and when.
  • Legible — readable and permanent.
  • Contemporaneous — recorded at the time of the activity.
  • Original — the first record (or a certified true copy).
  • Accurate — correct and free from errors.

Plus:

  • Complete — nothing deleted or hidden.
  • Consistent — logical and chronological.
  • Enduring — retained for the required period.
  • Available — retrievable for review and inspection.

Applying ALCOA+ in software

  1. Computer-generated, tamper-evident audit trails.
  2. Time synchronisation and user attribution.
  3. Controlled changes with review and approval.
  4. Robust backup and retention.

Anxya Health keeps ALCOA+ in mind across records and outputs. Educational content, not regulatory advice.

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