21 CFR Part 11 – System Access to Authorized Individuals

[COLOR=#333333]We all know the important of 21 CFR Part 11 and in particular how people access these systems on a regular basis. For those of you who are not familiar with this regulation it is referenced in 21 CFR Part 11 Section 11.200 Electronic Signature Components & Controls:
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[COLOR=#333333]i When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.
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[COLOR=#333333]i 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.
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