ALCOA+

 ALCOA+ is an extension of the ALCOA acronym, which stands for Attributable, Legible, Contemporaneous, Original, and Accurate. ALCOA+ adds four additional criteria for data integrity:

  1. Complete: All data should be recorded in full, without any missing information.

  2. Consistent: Data should be consistent and uniform across all records and documentation.

  3. Enduring: Data should be maintained for the entire required retention period.

  4. Available: Data should be easily accessible and available for review, inspection, and audit purposes.

ALCOA+ is used as a framework for ensuring data integrity in regulated industries such as pharmaceuticals, medical devices, and biotechnology. The ALCOA+ criteria help ensure that data is reliable, accurate, and can be trusted for making critical decisions. Adherence to ALCOA+ principles is essential for maintaining compliance with regulatory requirements and for ensuring patient safety and product efficacy.

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