ALCOA+ Principles in Pharmaceutical Indusrty


Attributable – Each entry traceable to the responsible individual

Legible – Clear, permanent, and audit-ready records

Contemporaneous – Entries made in real time during activity

Original – Source data or verified true copies

Accurate – True representation of the actual activity

Complete – Includes all data (repeats, deviations, corrections)

Consistent – Chronologically ordered with aligned timestamps

Enduring – Recorded in controlled, durable formats

Available – Readily retrievable during audits and inspections


Related Topics:

AuditCSVData Integrity
BioavailabilityBiotechnologyBioinformatics

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