Glossary
Contemporaneous
The property of data being recorded at the time the work or observation is performed.
Source · PIC/S PI 041-1 (2021), §7.4 ALCOA principles
Details
Contemporaneous recording preserves the real order of work by preventing later transcription from memory or informal notes. Inspections cite pre-signed records, batch entry at the end of a shift, and uncontrolled transcription from scrap paper into the official record. Check working time against system time, access to records at the point of work, control of original notes, batch and equipment logs, and audit trails.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You failed to perform contemporaneous two-person checks during the reading of environmental (b)(4) plates and subsequent data entry of the results in your (b)(4) software system.
FDA · FDA Warning Letter · 2025-07-03 -
Your laboratory control data was not recorded contemporaneously.
FDA · FDA Warning Letter · 2026-03-10 -
You failed to ensure that batch records are complete, and that all manufacturing activities and operations are recorded contemporaneously.
FDA · FDA Warning Letter · 2026-01-06
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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