We are currently working on the forum. For the short-term, all forum content will be in read-only format. We apologize for the interruption and look forward to collaborating with you shortly. All the best in your research!
21_CFR_Part_11 compliance
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
0
Comments
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