Compliance
Data integrity
alcoa · alcoa+
ALCOA+ — data must be Attributable, Legible, Contemporaneous, Original, Accurate (+ Complete, Consistent, Enduring, Available).
Data integrity is the foundation of every regulator's inspection mindset. The ALCOA+ acronym summarises what GMP-grade data must be: Attributable to a person, Legible, Contemporaneous (recorded at the moment), Original (or true copy), Accurate, Complete, Consistent, Enduring (durable), Available.
V5 enforces ALCOA+ structurally: kiosk capture is contemporaneous, every row is attributed to a logged-in user, audit trail makes records enduring and complete, PDFs are true-copy renders of the underlying snapshot.
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