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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

It’s an acronym we hear all the time in the trial master file industry. But what does it mean? Quality check? Quality control? Well, it can actually mean both—but more on that later. When it comes to ensuring the quality and inspection readiness of your trial master file, QC (in both of its forms) is absolutely crucial.

Defining a successful QC strategy can be the difference between barely meeting your objectives and crushing those KPIs. But not everyone has the experience or knows exactly what to check when performing TMF QC. Luckily for you, though, there is a way forward! In this article, we’ll discuss how you can identify the different levels of QC to be carried out based on the final scope of the activity, why each of these different types of TMF QC is essential for maintaining the health of your trial master file, and how to define your QC strategy. 


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