How to set up eTMF quality checks in three simple steps

Sep 15, 2022

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!

More about eTMF

WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management

WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management.

Learn more
RWE-ready eTMF for 24/7 transparency in your documents

To make everyone’s lives easier, we added a template for RWS to our eTMF – you can select it when you create an eTMF structure for the project from the list of default templates. 

Learn more
SOLTI academic research group gets full transparency of clinical operations with Flex Databases CTMS and eTMF implementation

With Flex Databases CTMS & eTMF implementation, SOLTI aims to perform detailed analysis based on the information included in the system, have an operational data repository easy to consult and to easily extract reports of transversal data for company statistics and performance over the years.

Learn more
5 examples of data sets that are shared between Flex Databases CTMS & eTMF

Flex Databases CTMS & eTMF are interconnected to deliver you the highest possible level of data completion and avoid missing documents issues.

Learn more

Have we picked your interest?

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.