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AchievingCFRPart11Compliance-2022

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Section # Requirement Compliance/Documentation/Comments<br />

AutoSave Software<br />

C/11.200<br />

(a)<br />

(i)<br />

(ii)<br />

Electronic signature components and<br />

controls<br />

Electronic signatures that are not<br />

based upon biometrics shall:<br />

(1) Employ at least two distinct<br />

identification components such as an<br />

identification code and password.<br />

When an individual executes a series of<br />

signings during a single, continuous<br />

period of controlled system access, the<br />

first signing shall be executed using all<br />

electronic signature components;<br />

subsequent signings shall be executed<br />

using at least one electronic signature<br />

component that is only executable by, and<br />

designed to be used only by, the<br />

individual.<br />

When an individual executes one or more<br />

signings not performed during a single,<br />

continuous period of con-trolled system<br />

access, each signing shall be executed<br />

using all of the electronic signature<br />

components.<br />

(2) Be used only by their genuine owners.<br />

(3) Be administered and executed to ensure<br />

that attempted use of an individual’s<br />

electronic signature by anyone other<br />

than its genuine owner requires<br />

collaboration of two or more individuals.<br />

(b)<br />

Electronic signatures based upon<br />

biometrics shall be designed to ensure<br />

that they cannot be used by anyone other<br />

than their genuine owners.<br />

Each User ID has a unique password<br />

associated with it ensuring that the<br />

electronic signature has two distinct<br />

identification components.<br />

The User ID and password are required to<br />

login and also to perform subsequent<br />

actions ensuring that at least one electronic<br />

signature component is required by an<br />

individual executing an electronic signature<br />

at any given time of use.<br />

The User ID and password are required to<br />

login and also to perform subsequent<br />

actions ensuring that at least one electronic<br />

signature component is required by an<br />

individual executing an electronic signature<br />

at any given time of use.<br />

System access is granted based on a<br />

unique combination of User ID and<br />

password issued to only authorized users.<br />

System access is granted based on the<br />

unique combination of the User ID and<br />

password ensuring that the use of an<br />

electronic signature by anyone other that its<br />

genuine owner will require the collaboration<br />

of two or more individuals.<br />

N/A<br />

No biometrics used.<br />

12

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