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Confimedis Platform v3.12.0

Overview

Scope Feature
Version v3.12.0
Release date June 15, 2026
Deployed to Confimedis Cloud June 15, 2026
Affected modules Documents, Forms

Validation

Validation by Confimedis

Confimedis GmbH has validated this release in accordance with its quality management system and GAMP 5 before deployment, re-executing the test cases of the Operational Qualification (OQ) for the affected functions according to their risk classification. A release does not change the configuration of your study, such as forms, edit checks, roles, or users, which your Performance Qualification (PQ) covers. Where existing settings are migrated, the note says so. The Validation Package of every release, including the OQ report and a prefilled Validation Summary Report (VSR), is available on request and only needed for an initial validation or a revalidation. A test project is a copy of your study without patient data, created via CDISC ODM export and import.

This release predates the introduction of Release Impact Statements. Its changes are listed below.

Changes

Features

  • Documents: Initial Electronic Trial Master File (eTMF) Support
    • The Confimedis Platform now supports electronic Trial Master File (eTMF) management, where study documents are maintained in a structured review and publish workflow and classified according to the CDISC TMF Reference Model.
    • Each document version moves through the statuses Draft, Review, Published, and Rejected, shown as colored badges, with the available actions (Submit, Withdraw, Approve, Reject, Publish, and Unpublish) depending on the version’s status and the user’s permissions.
    • Three new permissions (Draft documents, Review documents, and Publish documents) split the workflow across roles, complementing the existing Manage all documents and read-only View published documents permissions.
    • Approving and publishing a version now require re-authentication with an electronic signature and a reason, both recorded in the audit trail so that it stays traceable who changed a document, when, and why.
    • The complete version history can be opened from a document’s menu, and any two versions can be compared side by side in a GitHub-like view that highlights their differences.
    • Documents can be tagged with their TMF zone and section, so that the overall document collection can be aligned with the CDISC TMF Reference Model.

Improvements

  • Forms: Removing an assignment, such as a form from an event, is now blocked when data has already been collected there, as this would otherwise hide the data.

Bug fixes

  • Forms: Fixed an issue where publishing or unpublishing a form version only updated the form in the currently opened event, leaving its references in other events on the previous version.