What is ALCOA+?
Data integrity principle: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available. The gold standard for pharmaceutical data integrity.
ALCOA+ describes what makes a record trustworthy: every entry can be traced to the person who made it, is readable, was recorded at the time the work happened, exists as (or traceably derives from) the original observation, and is correct — plus the record set is complete, consistent, durable, and retrievable on request.
Data integrity findings are among the most serious in FDA inspections because they undermine confidence in every other record. Common failures include backdated entries, shared logins, transcribing readings hours later, and 'tidying' original values without preserving the original.
See how CompliRx handles this in practice:
Document control softwareRelated terms
Turn the standard into daily records
CompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.