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Confimedis Platform v2.5.0

Overview

Scope Feature
Version v2.5.0
Release date November 3, 2024
Deployed to Confimedis Cloud —
Affected modules 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

Features

  • Subjects: Bulk signatures
    • Users may now sign (and optionally lock) all forms of a given subject or event at once.

Improvements

  • For long forms, the footer now floats at the bottom of the screen for quick access to save and close options.
  • An error is now shown when a user attempts to assign an already occupied variable name to an element.
  • User roles can now be exported and imported in the CDISC ODM format.
  • An item may now have multiple validation rules (i.e., range checks) assigned to it.