ALCOA and ALCOA+ refer to a set of principles essential in ensuring the integrity and quality of data, particularly in scientific and regulatory environments. Initially, ALCOA stood for five key attributes: Attributability, Legibility, Contemporaneity, Originality, and Accuracy. These principles are foundational in ensuring that data is reliable and trustworthy.
- Attributability: This aspect emphasizes the importance of identifying the individual responsible for data entry or performing a specific action, along with the time of such activities.
- Legibility: This principle ensures that all records are clear, readable, and permanent, thus enhancing their accessibility and usefulness throughout their lifecycle.
- Contemporaneity: It stresses the need for data to be recorded or documented at the time the particular activity occurs.
- Originality: This refers to the creation of a primary record, which could be a first-hand observation, written note, printout, or any initial report.
- Accuracy: Accuracy is crucial, demanding that the data be correct and free from errors. Any modifications should be well-documented and justified.
These core principles were later expanded to form ALCOA+, adding four additional concepts: Completeness, Consistency, Endurance, and Availability.
- Completeness: This ensures that all data, including any repeated analysis or tests performed, are thoroughly recorded.
- Consistency: This involves maintaining a logical flow in data recording, where all parts of the analysis or process are sequentially dated or time-stamped.
- Endurance: This principle advocates for data to be recorded in durable and reliable formats, not on transient or unreliable mediums.
- Availability: It guarantees that data remains accessible for review, audits, or inspections throughout its useful life.
These principles collectively ensure the integrity, reliability, and traceability of data, making them fundamental in fields that demand high standards of documentation and data management.
