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Confimedis Platform v3.11.0

Overview

Scope Feature
Version v3.11.0
Release date June 8, 2026
Deployed to Confimedis Cloud June 8, 2026
Affected modules Export, Reports, Subjects, Randomization, 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

  • Export: Audit trail CSV export with custom timeframes
    • In addition to the CDISC-ODM and PDF/A exports and the integrated audit trail views, the entire audit trail can now also be exported in CSV format.
    • The export includes all changes made to subjects (e.g., keys, locations, arms), to the form status (e.g., the form version number), and to item data (e.g., values, SDV).
    • A custom timeframe can be selected for the data to be exported (e.g., a single month or the entire study).

Improvements

  • Reports: The integrated audit trail report now shows many translated, user-friendly labels instead of reference IDs.
  • Subjects: The subject audit trail slideover now also shows updates to queries of a selected subject.
  • Randomization: Randomization schedules can now be exported in CSV and PDF format, with or without the treatment group label.

Bug fixes

  • Forms: Fixed an issue where the condition and mandatory settings could not be edited on a new draft of a versioned form.