[James OKeefe]

Hi Katie:

Are the study files coming from an eTMF?

Amazon web services generally is not very user friendly all on its own.

If the study files are coming from some content management system, you can store them in file shares, SharePoint or a host of other options.

I have in the past in this situation used the exported metadata and files to systematically build an excel file (or series of files depending on how big the study file is) to use as an index for easier navigation to the destination file share or SharePoint site.

Iron Mountain also has electronic archiving solution.

Jamie O’Keefe
O’Keefe Life Sciences, LLC
Jamie@okeefelifesciences.com

[James OKeefe]

You also need to be mindful of how many dates for a given document you are going to track and save in your eTMF, and is there real value in the effort.

Possible dates, for any single doc: Drafted, Issued, Approved, Sent, Received, Filed, Expiry, etc

Thats a LOT of dates.

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