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FDA 21 CFR part 11 requirements

Question asked by Teemu Hakala on Mar 29, 2016
Latest reply on Apr 21, 2016 by Wayne Marshall

Food and Drug Administration requires medical device company to fulfill part 11 requirements of electronic signatures.

That part says the following:


"Sec.11.200 Electronic signature components and controls.

 

(a) Electronic signatures that are not based upon biometrics shall:


(1) Employ at least two distinct identification components such as an
identification code and password

...

(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."

 

Have you somehow (by some other way) managed to fulfill these requirements with Solid Works Enterprise PDM since there is only possible to set the software to ask user´s password, not username also?

 

Also, according the requirements, there should be username and password to input by the user when logging in to system. Now the username field is already fulfilled by the system and it is not possible to set empty as a default.

 

 

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