Glossary
Electronic Signature
Data generated electronically to show the identity of the signer and their responsibility for an electronic record.
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.
