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Confimedis Platform v3.8.1

Overview

Scope Maintenance
Version v3.8.1
Release date April 20, 2026
Deployed to Confimedis Cloud April 20, 2026
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

Improvements

  • Subjects: Invalid soft range checks are now highlighted when opening a form and rendered in yellow to stand out as warnings. Moreover, newly created range checks are now hard by default, with the option to mark them as soft when needed.
  • Subjects: Support custom validation rules (including comparative expressions) for items with codelists (i.e., predefined field choices).

Bug fixes

  • Subjects: Fixed an issue where validation rules with comparative expressions were always handled as hard checks, even when configured as soft checks.
  • Users: Updated two overly restrictive Row Level Security (RLS) policies that prevented users who are not project owners from configuring notification timings and versioning documents.