Glossary
Electronic Record
A record in digital form that a computer system creates, modifies, stores, retrieves, and distributes.
Source · PIC/S PE 009-17, Annex 11, Computerised Systems; MFDS, 「알기 쉬운 GMP 용어집」, Electronic record Korean original
Details
An electronic record is digital information created, modified, maintained, archived, retrieved, and distributed by a computer system, and the meaning and context of that data must be preserved. Inspections cite failure to demonstrate lifecycle control, access rights, audit trails, electronic signatures, long term readability, or that the record is original and accurate. Check the system inventory, data flows, the URS and validation, the privilege table, audit trail review, and backup, recovery, and retention records.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your Quality Unit failed to ensure adequate control over paper and electronic records.
FDA · FDA Warning Letter · 2026-09-29 -
Your quality unit (QU) failed to ensure adequate document control over paper and electronic records.
FDA · FDA Warning Letter · 2022-12-13 -
You failed to ensure adequate document control over paper and electronic records.
FDA · FDA Warning Letter · 2025-03-25
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Annex 11, Computerised Systems; MFDS, 「알기 쉬운 GMP 용어집」, Electronic record Korean originalGRM Regulatory Glossary
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