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🖥️ Distinguishing Electronic Signatures from Event Attribution in the Pharmaceutical Industry Understanding the crucial difference between electronic signatures and event attribution in audit trails is paramount for compliance and security in the pharmaceutical sector, particularly under FDA’s 21 CFR Part 11. Electronic Signatures: - Definition: A legally binding signature requiring user authentication. - Compliance: As per FDA’s 21 CFR Part 11, electronic signatures necessitate password authentication to verify the signer's identity. - Security: Prevents unauthorized signing, ensuring additional password entry if a device is left unattended. Workflow: - User Authentication: Users input their password. - Signature Execution: System confirms the password and logs the electronic signature. Event Attribution in an Audit Trail: - Definition: Attributing actions to a user in an audit trail via automatic system logging. - Difference: Doesn't demand real-time user authentication for each event but relies on prior authenticated sessions. - Example: Actions within an active session are linked to the user, posing a risk if the session is unsecured. Key Differences: - Authentication: Electronic signatures mandate immediate user authentication (at least password) for each signing event. - Security: Offers enhanced security by preventing unauthorized signing on unlocked devices. #PharmaceuticalIndustry #ElectronicSignatures #AuditTrails #Compliance #SecureDocumentManagement #FDA21CFRPart11 #GMP #PharmaIndustry #PharmaCompliance #21CFRPart11 #GXP