R
ryno fan
Hi,
The FDA regulation on CFR 11-Electronic Records; Electronic Signatures (specifically 11.200 Electronic signature components and controls) requires that:
(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.
In the scenario where the authorized user has control over the system but is simply not using it (has it open, but is performing other tasks at his desk) - Does anyone know of a standard amount of time (from FDA or other guidance) after which an electronic system is expected to prompt the user for "all of the electronic signature components" after such a period of inactivity? (are there rules on "system timeouts"?) :
Thanks
The FDA regulation on CFR 11-Electronic Records; Electronic Signatures (specifically 11.200 Electronic signature components and controls) requires that:
(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.
In the scenario where the authorized user has control over the system but is simply not using it (has it open, but is performing other tasks at his desk) - Does anyone know of a standard amount of time (from FDA or other guidance) after which an electronic system is expected to prompt the user for "all of the electronic signature components" after such a period of inactivity? (are there rules on "system timeouts"?) :
Thanks
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