Glossary
Electronic Signature
Data generated electronically to show the identity of the signer and their responsibility for an electronic record.
Source · PIC/S PE 009-17, Annex 11, §14 Electronic Signature; MFDS, 「알기 쉬운 GMP 용어집」 Korean original
Details
The electronic signature is a data control concept that allows GMP activities and decisions to be reconstructed completely in both paper and electronic environments. Inspections cite shared accounts, audit trails not enabled or not reviewed, missing raw data or metadata, and deletions and reprocessing recorded without a reason. Check the system inventory, the URS and validation, user privileges, audit trail review, and backup, recovery, and raw data retention records.
Related sections
Related terms
Real inspection findings
See 73 findings whose text contains this termCounted 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, §14 Electronic Signature; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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