Data integrity has always been a critical point during the development of eTMF systems. One of the industry’s latest standards is ALCOA++, and our eTMF module is 100% compliant with ALCOA++.
Let’s see what advantages it brings to our clients.
In our eTMF module, all actions conducted with each item are caught, kept, and indicated: who and when uploaded the file; all updates’ details are transparent and can be easily found right in the system. Extra attributes such as metadata can be used to mark documents for easy search or personal list creation.
Each item of eTMF has version history and actual information in easy-to-read format within the system.
All dates are available in the system’s interface. All the dates are indicated in one format in the whole eTMF module to avoid misunderstanding.
The original records are permanently preserved in the system to save data meaning and integrity. Moreover, we can arrange a direct flow of the initial documents from sites into the system. In case of duplicates, the creator of the original record should confirm the authenticity of the copies.
Our eTMF module allows its users to create amendments of any kind to the files, keeping a trail in the system. The version changes automatically, letting the users know all the actions taken to the file.
Complete
Placeholder-based visual statistics allow observing the eTMF completeness at any moment. If some previous or deleted versions are needed – you can reach them in the audit trail.
Consistent
As soon as an item is updated new version is tracked in the system automatically so that the content changes can be quickly investigated. When there comes an audit, you will be ready at no time.
Enduring
Stored data cannot be corrupted anyhow – all content changes are fixed at the log; any potential storage problems are covered by regular backups executed by the system automatically.
Available
eTMF web application allows the documents to be available 24/7 from any corner of the Earth.
Traceable
Timestamps with time zones specified allow eTMF to cover the last + of the ALCOA ++.
The reason for deletion provides an opportunity to trace even the necessity of action.
Reach out to our BD team at bd@flexdatabases.com to learn more about the eTMF module or to schedule a demo.
iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials
At Flex Databases, we aim to take you out of the vicious cycle by offering flexible workflow – to put it simply, a LEGO set of features that you can build however you like, to fit existing project requirements and SOPs, to adjust a system to you.
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.
`”AXIS is implementing Flex Databases CTMS as we see this as an excellent full-service software that will enable us to have management of all our research systems under one platform.”
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.