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.
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!
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.
Flex Databases CTMS & eTMF are interconnected to deliver you the highest possible level of data completion and avoid missing documents issues.
We asked CEO André Warnke a couple of questions about the upcoming partnership
iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials
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.