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Confimedis Platform v3.1.0

Overview

Scope Feature
Version v3.1.0
Release date December 9, 2025
Deployed to Confimedis Cloud —
Affected modules Users, Documents, General, Subjects

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

Improvements

  • Users: The server email template now includes a one-line summary for invite and password reset emails.
  • Documents: Referenced PDF documents in forms, e.g., for informed consents, are now embedded in PDF/A exports.
  • General: Unified and extended visual loading indicators across the application, e.g., when creating and updating queries.
  • Subjects: Single choice fields now allow answers to be deselected, even when the item is mandatory.

Bug fixes

  • Users: Solved a rendering issue that sometimes led to an infinite loading spinner at the top of the user form after inviting a new user to a project.
  • Users: Fixed a server-related problem that resulted in system users not being deleted after the last associated project user has been deleted.
  • Users: Corrected a permission issue that resulted in an error when trying to import metadata without the Edit project settings permission.