Reply To: Electronic TMF

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Eldin Rammell

I agree with Karen. You can’t beat talking to people who have already made the journey.

One of the primary drivers for using an eTMF that I mention when talking to people is to just think about how we do our work in the 21st century. We create documents using computer software, creating electronic documents. Even when our TMF is allegedly paper, we still collaborate with each other electronically. When we need to see a document, we go to SharePoint, our email, or a network drive to get the information we need. We send around documents electronically by email. And most critically, we rarely work just in one geographic location so we need the ability to access documents from wherever we are located.

So given this working scenario, why would we print everything and retain it using a medium that limits sharing and limits access? A printout is a secondary copy and contains almost none of the metadata generated during the life of the original; best to keep the original e-record in an eTMF!

I’m sure others can provide some additional insights.