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.
