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

July 31, 2025
How Much ROI Can You Expect from eTMF and CTMS? 

A Comparative Look at Europe vs. US Markets  In clinical operations, time is money – but how much money can technology really save you? We analyzed the return on investment (ROI) for implementing electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) based on real-world benchmarks. By modeling savings from reduced manual effort, […]

July 29, 2025
The Flex Databases team is looking for a QA Engineer / Tester. 

📍Remote 💼Full-Time We are driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies.  We work globally with clients all over the world, with our own offices located in the Czech Republic, Switzerland, Turkey, and the US. […]

July 22, 2025
Electronic Data Capture – Everything You Need To Know

What is Electronic Data Capture? Electronic Data Capture (EDC) is an electronic system applied to clinical trials for capturing, managing, and storing patient data. Instead of paper-based forms, investigators enter clinical trial information directly into a secure, web-based site. EDC systems validate data integrity, reduce errors, and automate the data collection process – accelerating clinical […]

Data Hosting with Confidence – Flex SaaS for Clinical Trial Environments 

At Flex Databases, we deliver a SaaS solution purpose-built for clinical trials – offering global accessibility with full transparency and control over where your data resides.  Not a Public Cloud. A Dedicated SaaS Platform You Can Trust.  Flex Databases is an EU-based company operating globally and trusted by life sciences organizations for secure, validated SaaS […]

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.