How to set up eTMF quality checks in three simple steps

September 15, 2022

How to set up eTMF quality checks in three simple steps

The difference between a paper Trial Master File and an electronic one is not only the storage and availability of documents. eTMF allows you to stay on top of your documentation in terms of quality – and here’s an instruction on how to set up Quality Checks in Flex Databases eTMF.

In Flex Databased eTMF, quality checks are part of metadata. We have a special metadata category called “Quality” (surprise!), and all metadata fields of this category have a dedicated report on a dashboard, so you’d get all the information about the quality of your documents at a glance.

Step 1: Create a new Metadata field

Step 2: Add the field you created in the project settings

Step 3: Check the new check field

And now you can see it in the report!

The quality check tool is flexible to cover all your needed SOPs’ requirements and team requests. Since any information can be presented as metadata, you decide on exact characteristics that should be checked in different parts of your TMF. You can predefine the quality checks for a specific placeholder, files, or even information resources, like users or sites – any filter is available in our eTMF. 

Always stay on top of your quality with Flex Databases eTMF. Request a demo or contact us through bd@flexdatabases.com to learn more!

Blog

October 13, 2026
The Holy Triangle of TMF:  Is It Really Enough to Measure TMF Health by Tracking Its Completeness? 

When vendors build tools to evaluate TMF health, they usually focus on three main KPIs: completeness,  timeliness and quality.  These metrics are obviously important, but are they enough?  A real TMF user will go further and ask the next question:  How long did it take the document to move through each of these stages?  The […]

September 29, 2026
EDC Data Solution Specialist (Data Manager)

As an EDC Data Solution Specialist (Data Manager), you will work at the intersection of data, systems, and clinical research. You will translate clinical study requirements into practical EDC solutions – from understanding study protocols to building and testing electronic forms, configuring validation rules, and supporting clinical data throughout the study lifecycle. We are looking […]

September 24, 2026
How ITS Achieved 98% TMF Completeness and Cut Audit Prep Time in Half

About Integrated Therapeutic Solutions Integrated Therapeutic Solutions (ITS) is a clinical research organization (CRO) specializing in multi-country clinical trials. As ITS expanded its sponsor portfolio and study volumes, it demanded a document management infrastructure capable of keeping pace – one that could ensure regulatory compliance, support sponsor oversight, and maintain operational control across a growing […]

September 14, 2026
Flex Databases Product Updates: EDC, IWRS & eCRF Builder Updates That Remove Manual Work From Study Teams

Every month, Flex Databases ships updates driven by real friction our clients run into on active studies. July’s release focuses on one theme in particular: removing manual, repetitive work that takes up study teams’ time and creates avoidable errors. From protecting critical configurations to automating bulk data entry and site-specific workflows, these updates address everyday […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.