Glossary
Attributable
The property of being able to identify who, or which system, performed a recorded action or change, and when.
Source · PIC/S PI 041-1 (2021), §7.4 ALCOA principles
Details
Attributability lets the responsibility for, and the time order of, data creation, modification, and deletion be reconstructed. Inspections cite shared IDs, signing on behalf of someone else, undated corrections, and automatically generated data whose source cannot be identified. Check signatures and user accounts, time synchronisation, audit trails, and the controls over record correction and electronic signatures.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
FDA · FDA Warning Letter · 2026-10-13 -
A management strategy for your firm that includes the details of your global CAPA plan to implement attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation.
FDA · FDA Warning Letter · 2026-09-29 -
Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation.
FDA · FDA Warning Letter · 2026-10-13
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PI 041-1 (2021), §7.4 ALCOA principlesGRM Regulatory Glossary
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