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.

Thank you for reading this post, don't forget to subscribe!

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

May 26, 2026
Looking for an Enterprise eClinical Solution? There Is More to Consider

When evaluating core clinical research platforms, most companies naturally start with the well-known enterprise brands. Thank you for reading this post, don’t forget to subscribe! They are recognizable, widely adopted, and often positioned as the “safe choice” for regulated environments. But once the demo phase is over and implementation actually begins, many teams discover that […]

May 21, 2026
Vendor Oversight Under ICH E6(R3): Why Compliance Expectations Are Higher Than Ever

Vendor oversight has always been part of clinical trial compliance, but ICH E6(R3) has significantly raised expectations for sponsors and technology vendors alike. Thank you for reading this post, don’t forget to subscribe! The updated guideline makes one thing very clear: sponsors remain fully responsible for trial quality, patient safety, and data integrity — even […]

Senior Project Manager | eClinical

We are looking for seasoned Senior Project Manager who is ready to take full ownership of high-impact projects. At our core, we value delivery over slides and results over rigid hierarchy.  Thank you for reading this post, don’t forget to subscribe! Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical […]

May 19, 2026
Clinical Trials Management Software: Key Features for CROs

CROs work in a fast-moving and highly complex environment. They manage multiple studies at the same time, often for different sponsors, across different countries, sites, and timelines. Each study comes with its own processes, reporting needs, and regulatory expectations. As this complexity grows, it becomes harder to keep everything aligned using separate tools or spreadsheets […]

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.

[ninja_form id=4]