ALCOAPrinzip

The ALCOA principle is a data integrity framework used in regulated industries such as pharmaceuticals and clinical research to ensure the reliability of records and data throughout their lifecycle. It provides a set of attributes that data should meet to be trustworthy and compliant with quality systems and regulatory expectations.

- Attributable: actions and data should be attributable to a person with identifiable date and time, enabling traceability.

- Legible: records must be clear, readable, and capable of being reviewed.

- Contemporaneous: data should be recorded at the time of the event or observation.

- Original: data should be the original record or a certified true copy, not a substitute.

- Accurate: information must be correct and precisely recorded.

ALCOA+ builds on ALCOA by adding four attributes to address broader data integrity needs:

- Complete: data and metadata should include all relevant information.

- Consistent: data should be consistent across systems and over time.

- Enduring: records should be durable and resistant to undisclosed alteration.

- Available: data should be accessible to authorized personnel when needed.

In practice, ALCOA is applied to both paper and electronic records, including laboratory data, instrument outputs, and audit trails. It is widely referenced in GMP environments and regulatory guidance, such as GMP data integrity expectations and related parts of the FDA and ICH frameworks. Implementation typically requires documented policies, validated systems, adequate training, robust access controls, and ongoing quality-system controls to ensure that data adhere to the ALCOA principles throughout their lifecycle.