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Confimedis Platform v2.2.0

Overview

Scope Feature
Version v2.2.0
Release date September 23, 2024
Deployed to Confimedis Cloud —
Affected modules Forms, Documents

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

  • Forms: Reuse of codelists
    • The codelist panel now renders previously defined codelists and allows you to reuse them.
    • Codelists are reused by reference rather than by copying them, and the number of references is shown for each codelist.
  • Documents: File uploads in documents
    • The documents module now allows the upload of files while rendering PDFs, images, and videos.
    • Versioning is supported by uploading new file versions for a specific document.
    • When referenced in forms, supported files are rendered there as well.

Improvements

  • Reports and CSV exports now render event and form names in dedicated columns and only include each item once, even if it is referenced in multiple events or forms.