Data integrity assessment according to ALCOA++: Flex Databases eTMF is fully compliant

May 20, 2022

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. 

A – Attributable  

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.

L – Legible 

Each item of eTMF has version history and actual information in easy-to-read format within the system.

C – Contemporaneous 

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.

O – Original 

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.

A – Accurate

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.

More about eTMF

TMF Quality Review 2.0 

Periodic TMF reviews automatically documented. Quality and completeness under control!

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Archiving eTMF for 25 years? Secure, accessible, and compliant with Flex Databases 

Flex Databases offers a solution for all your archiving needs.

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

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

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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. 

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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.