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21_CFR_Part_11 compliance

vsanghvivsanghvi Posts: 10
in Users Mailing List
Hello sir,
This statement is specified in 21_CFR_Part_11_and_Electronic_Signatures_Guidelines_for_OpenClinica_Developers_v1.0.pdf
Signature Controls (for signatures based on passwords) include:
o Use of at least two distinct id components such as an user id and password.
o Signature Verification:
§ 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.
§ 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.
but i am confused about
does OC supports this signature control? if yes then how?
Thanks
VIKRAM

Comments

  • vsanghvivsanghvi Posts: 10
    Hello sir,
    This statement is specified in 21_CFR_Part_11_and_Electronic_Signatures_Guidelines_for_OpenClinica_Developers_v1.0.pdf
    Signature Controls (for signatures based on passwords) include:
    o Use of at least two distinct id components such as an user id and password.
    o Signature Verification:
    § 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.
    § 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.
    but i am confused about
    does OC supports this signature control? if yes then how?
    Thanks
    VIKRAM
This discussion has been closed.