What makes a record auditable in GLP?

• A. It is complete, legible, attributable, contemporaneous, original, and readily available for review and reproduction
• B. It is confidential and not easily accessible
• C. It is encrypted and stored offsite
• D. It is created by automated systems only

Answer: (A)

Auditable records in GLP are built on ALCOA principles: complete, legible, attributable, contemporaneous, original, and readily available for review and reproduction. This combination ensures data integrity and traceability throughout the study. Complete means every relevant data point and its context are captured, including calculations and any amendments. Legible ensures that anyone can read the information later. Attributable means it’s clear who created or modified the data and when, establishing responsibility. Contemporaneous means entries are made at the time of the activity or as soon as possible, preserving the true timing of events. Original means the initial record or its approved, authentic copy is preserved, not a later or altered version. Readily available for review and reproduction means auditors can access the records and reproduce the results or steps exactly as they occurred. This combination is what makes a record trustworthy and audit-ready. Confidentiality or restricted access, encryption with offsite storage, or records produced only by automated systems do not by themselves ensure these auditability criteria; they must still be accessible, traceable, and preserved in their original form.