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The 5 W's of eTMF Planning

Oliver Pearce


As with most critical business processes, proper planning can be the difference between success and failure. The same can be said for Electronic Trial Master Files. 

The use of Electronic Trial Master File (eTMF) systems in the Life Sciences has been increasing rapidly over the past few years. The increase in eTMF use has often meant organizations have rushed into eTMF, not putting in place the vital processes that will deliver eTMF success. 

As an eTMF vendor, Montrium helps life sciences organizations transition to eTMFs on a weekly basis. We are constantly reminding our clients of the change in mindset that is required as they transition to an eTMF, and that moving to an electronic system doesn't mean mimicking their  paper process. Meaningful eTMF planning at Montrium hinges on 5 key pillars, these are shown below.

What: Expected artifacts

Who: Roles and responsibilities

When: Milestones, Events, and timeliness standards

Where: Systems that hold the authoritative source

Why: Processes and events

Take a look at what the 5 W's of eTMF Planning really mean in this great infographic we put together. If you find the infographic useful, remember to share it on with your colleagues.


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