ALCOA

ALCOA is a common acronym summarizing the criteria of data integrity (the ALCOA principles). It stands for:

• Attributable (i.e., identification of the source, the data originator – person, device, or system)
• Legible (and understandable)
• Contemporaneous (i.e., recorded at the time)
• Original (the initial record itself – paper-based or electronic – or a certified/true copy)
• Accurate (i.e., the degree to which data reflects the original values or facts it represents)

The literature names additional criteria. The first plus adds four:

• Complete (i.e., all process-relevant data needed for sound decision-making)
• Consistent (relevant data, including changes, is recorded in the correct chronological order and with correct timestamps)
• Enduring (recorded on suitable media – no Post-its, backs of pages, or loose uncontrolled sheets; flat files or USB drives only with controls: access, metadata, backup)
• Available (i.e., data remains available across the entire data lifecycle – for audits, inspections, reviews)

The second plus makes it ALCOA++: it adds Traceable – changes to the data can be reconstructed (who, what, when, why). ALCOA+ appears in PIC/S PI 041, among others; the extension by Traceable is used, among others, by the EMA guideline on computerised systems and electronic data in clinical trials (2023) – QFINITY consistently writes ALCOA++ for it.