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The Montrium Blog

The most helpful and thought-provoking ClinOps content from our writers on the front-lines of the life sciences industry

We tend to think about the inspection readiness of a TMF in a rather superficial way. We’ll frequently ask ourselves about the completeness, timeliness, quality, and compliance of the TMF—but we fail to consider what truly drives these outputs. What is it that determines whether your documents are routinely making it into the TMF one time? What is it that guides your level of quality and how compliant you are with the regulatory requirements? The answer: your process. Having a robust TMF management process can truly make or break an inspection. 
 
Processes are everywhere in our day-to-day life, even if we don’t always realize it. Think about a baker who’s preparing a cake. The baker must follow a process—or recipe—in order to complete his final deliverable. And while baking a cake may sound a bit more exciting and delicious (to some) than filing documents in your TMF, they’re both still activities where it’s necessary to follow a process in order to achieve a final deliverable that can withstand a visit from an inspector—the food kind or the regulatory kind. 
 
Keep reading to find out the proven formula for developing a TMF process—along with some best practices for doing so—and how to ensure that your TMF process is expert-approved. 

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