ALCOA

ALCOA is a common acronym for representing data integrity by meeting the following criteria:

• Attributable / attributable (i.e., source identification – human or technology)
• Legible / readable (and understandable)
• Contemporaneous (i.e. immediately recorded)
• Original (handwritten records or certified / true copies)
• Accurate (that means, no change (cave: permission correct?) or no change without justification)

In the literature, additional criteria are often cited leading to acronyms such as e.g. ALCOA (+) or ALCOA CCEA:

• Complete (i.e., all process-relevant data for robust decision-making)
• Consistent (relevant data are recorded in the correct chronological order and with correct timestamps)
• Enduring / permanent (recorded on appropriate media – i.e. no sticky notes, back pages, loose uncontrolled sheets, flat files or USB sticks)
• Available (i.e., data is available over the entire data lifecycle – e.g. for audits, inspections, reviews)

If you need more information about ALCOA contact us here or inform yourself on the Website of ISPE.