Regulatory Open Forum

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  • 1.  Part 11 Electronic Signatures / Compliance

    Posted 30-Nov-2017 08:21

    I have a question regarding how other sites use electronic signatures specifically for the review of external IND Safety Reports by the PI.  As many of you know trying to track down doctors for wet signatures can be time intensive and exhausting because of their schedules.  Electronic signatures allow for a quick, easy, and secure way to avoid this running around especially in large research centers.

    I appreciate any details you can give regarding your processes.  Do you use a portal of some sort? Simply have the PI or designee add an electronic signature to a NTF for review? How do you maintain compliance if electronic signatures are used?

    Thank you for your time!



    Josh Plassmeyer
    Regulatory Safety Specialist
    UPMC Hillman Cancer Center
    Pittsburgh, PA

  • 2.  RE: Part 11 Electronic Signatures / Compliance

    Posted 05-Dec-2017 12:42
    Hi Josh,

    Implementing Part 11 compliance is really not a big deal, in my opinion. Honestly its a great value add and process improver in clinical research where there are just a million documents most of which need constant updates & signatures. If following up with PIs is your pain point, I would suggest you take a look at e-regulatory software that are built for document compliance. These are easy to set up and don't need a lot of end user training - Complion, MedPoint RegDoc, MasterControl, Biooptronics are some s/w that come to my mind. You probably already have a trial management system - ask if they have an electronic file management module, that way you wouldn't need to go with a new vendor.

    Part 11 compliance also means your system is validated, this means secure logins and authentications, password protection etc. 21 CFR 11 does a good job of explaining what these requirements are and it is quite prescriptive. If you have a system into which each PI can securely login and e-sign the documents/safety reports (which would typically be routed to them for review) with a time stamp, you're good to go. One thing to keep in mind is that not all e-regulatory s/w meet all part 11 requirements (though they may claim complete compliance), it would up to you to identify gaps and establish appropriate procedures. Of course, all this is assuming your company wants to invest in this.

    A manual, makeshift file server based system is going to be hard to use and maintain, would also be time consuming. But not to say it has not been done. I would suggest looking at ACRP's resources for this because that is focused in clinical research.

    happy to answer more questions on this! I would also love to know if there are contradictory views.

    Vidyalakshmi Jayaraman
    Regulatory Affairs Specialist
    Marlborough MA
    United States