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  • 1.  Location of completed eCTD sequence folders - network drive versus SharePoint versus cloud

    Posted 13 days ago

    Hi there,

    I wanted to ask if anyone has experience with successfully maintaining the eCTD folder structure for completed sequences on a SharePoint site. This is unfamiliar to me, and I am used to seeing it maintained in a network/local drive location.

    Right now, I am unable to view sequences as the SharePoint drive is mapped to another individual's OneDrive location. I am concerned about the accessibility and shared nature of a website repository.  

    Thanks in advance for your input.

    Kind regards,
    Katelyn Mulligan



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    Katelyn Mulligan
    Associate Director, Regulatory Affairs
    ITB-MED
    New York NY
    United States
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  • 2.  RE: Location of completed eCTD sequence folders - network drive versus SharePoint versus cloud

    Posted 13 days ago

    Hi Katelyn,

    I am not qualified to comment on the relative security and accessibility of Sharepoint versus other cloud storage applications versus network/local drive options. It is my observation that there is a general trend toward cloud storage rather than hard media such as network or local drives. It would be my understanding that for you to obtain access to the Sharepoint is only a matter of permissions.



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    Glen Park PharmD
    Consultant
    Burien WA
    United States
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    Original Message


  • 3.  RE: Location of completed eCTD sequence folders - network drive versus SharePoint versus cloud

    Posted 10 days ago

    Good morning, Katelyn,

    I agree with Glen. However, in my experiences with SharePoint, it is not the best option for document control, especially if you need Part 11 compliance. You may want to look into other options, such as Veeva or Box. Both Veeva and Box can provide Part 11 compliance if you set it up correctly. Only certain versions of SharePoint are able to be Part 11 compliant; it is up to your company to determine which those are and if a compliant version is in use.

    https://learn.microsoft.com/en-us/answers/questions/771705/are-sharepoint-online-and-onedrive-fda-part-11-com

    https://sites.veevavault.help/gr/sitevault/support-training/audit/

    https://support.box.com/hc/en-us/articles/24169443030163-21-CFR-Part-11-Compliance-Support



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    Arvilla Trag RAC
    Principal Consultant
    CMC Compliance Services
    Iron River MI
    United StatesCMC Compliance Services LLC
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    Original Message


  • 4.  RE: Location of completed eCTD sequence folders - network drive versus SharePoint versus cloud

    Posted 8 days ago

    Hi Katelyn,

    I agree with Glen and Arvilla. In addition to my concerns around Part 11 compliance, I would also want additional information why it is tied to a person's individual OneDrive. What if they leave the company? It definitely sounds like there needs to be a bit more rigor around defining what this looks like. I also recommend using Box and Veeva.



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    Sheila Hittesdorf
    Vaxcyte Inc
    Hightstown NJ
    United States
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    Original Message


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