1 Reply Latest reply on Apr 21, 2016 4:18 AM by Wayne Marshall

    FDA 21 CFR part 11 requirements

    Teemu Hakala

      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.

       

       

        • Re: FDA 21 CFR part 11 requirements
          Wayne Marshall

          Teemu,

           

          I do not believe this is saying that they need to type in a user name, only that they must have a unique username / password combination. As for the electronic signature in this case this is achieved by combining the two methods below...

           

          • Do not use 'automatic log-in' to ensure Users are validated when they connect to the Vault
          • Add 'Authentication' to Transitions that require an electronic signature (e.g. Checked, Approved) - this prompts the user to enter their password a second time

           

          Take a look at this page and the accompanying document.

           

          Regulatory Compliance | SOLIDWORKS

           

          Kind regards

           

          Wayne Marshall

          Customer Support Mangager

          Solid Solutions Management (UK)