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

May 20, 2022

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

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.

Blog

September 2, 2025
What CROs Should Look for in CTMS and eTMF During a Tender

When preparing a tender for a Clinical Trial Management System (CTMS) and an electronic Trial Master File (eTMF), CROs must choose solutions that meet sponsor expectations and improve operational efficiency while keeping studies inspection-ready. The right choice affects study delivery, compliance, and client satisfaction. Below are the key factors CROs should consider. Regulatory Compliance and […]

August 28, 2025
Integrations in Clinical Trials: An IT/ETL Perspective

How Flex Databases connects your study ecosystem – reliably, securely, and at scale.  Why integrations matter to sponsors and CROs  Integration means that data entered once in a system of record is propagated automatically wherever it is needed. For clinical operations teams this translates into:  Core integration patterns we see most often  1) EDC → […]

August 14, 2025
Key Changes to EU Pharmacovigilance Regulation: What You Need to Know

In July 2025, the European Commission adopted Commission Implementing Regulation (EU) 2025/1466, amending Regulation (EU) No 520/2012. The changes aim to strengthen pharmacovigilance, reduce unnecessary administrative burden, and align EU requirements with global best practices. Most provisions apply from 12 February 2026, with certain Eudravigilance updates taking effect in August 2025. Why the Changes Were […]

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, […]

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.