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.

An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.

If you need more information about audits please contact us here.