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Achieving CFR Part 11 compliance

  • May 22, 2025
  • 4 replies
  • 27 views
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We are currently in the process of setting up Box GxP for the clinical trials division of our company.  The goal has been to essentially replace our network with the use of Box as part of our process to better meet Part 11 compliance requirements.  We understand that many organizations do this as two steps -- get Box up and running and then add the GxP component for compliance. I'd be interested in connecting with others where both functionalities are now happening.  We are struggling with implementation of certain types of documents (like highly formatted and fillable PDFs) as well as with how to integrate our current analytical software (we are a SAS shop and since Box doesn't integrate with SAS outside of the use of something like Proc HTTP, we are wondering how other integrate their analytical work whether it is with SPSS or R or Python or SAS....whatever you may be using).  Thanks for your input!

    4 replies

    C
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    Hi Sarah, 

    Welcome to the Box Community!

    You will need to get in touch with your Account Representative for concerns or questions related to setting up Box GxP validation or compliance as they would be the best people to discuss this subject with.

    Thanks for participation in the forum!

    Best,

    C
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    Thank you for the redirect and we are still working with our rep on our set up, but this integration with our analytics is where we have hit a bit of a wall.  We use SAS and there isn't a direct integration between SAS and Box so I was hoping to get feedback from others in the community about their experiences with analytic packages -- SAS, SPSS, R, what have you -- and using Box as the primary location for the data, programs, and outputs being generated. Is there somewhere else I should post if I am just looking for general feedback from other users in the Box community?

    C
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    Hi Sarah
    I don't have all the answers to your questions, but we can have a chat and I can share my experience regarding 21 CFR Part 11 / Box integrations. Send me your contact info, your availability and I'll reach out to you.

    Thanks

    C
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    Sayed -

    Thanks for the offer - my email is sarahwoodruff AT westat DOT com.  If you send me a note, I'll suggest some times to chat.  I appreciate it!

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