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Confimedis Platform v2.11.0

Overview

Scope Feature
Version v2.11.0
Release date May 26, 2025
Deployed to Confimedis Cloud —
Affected modules Subjects, Users

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

  • Subjects: Delete form data
    • For each subject, a new menu option allows you to delete all data and the status of a selected form.
    • For repeating forms, the selected instance will also be removed.
    • Deletion requires permission and is recorded in the audit trail.
  • Users: Required two-factor authentication
    • The owner of a project can now mandate two-factor authentication (2FA) for all users.
    • If a user without 2FA enabled attempts to access such a project, they will see an error with an option to enable it.

Improvements

  • When a form is unselected from all events in the assignment matrix, an error message now prevents losing the reference to it.
  • Improved the performance of file uploads, downloads, and previews.