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Confimedis Platform v2.3.0

Overview

Scope Feature
Version v2.3.0
Release date October 14, 2024
Deployed to Confimedis Cloud —
Affected modules —

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

  • Range checks can now be defined as “soft” or “hard,” where soft checks only give a warning instead of preventing data from being saved.
  • A regular expression can now be specified in the settings to define and constrain the format of manually entered subject keys.
  • Added a new permission that is required for a user to be able to delete subjects.
  • Support for custom translations has been added via an addTranslationOverwrite API.
  • There is a new option to batch export multiple CSV files, split by event and form.
  • A new permission allows forms to be locked independently of their verification status.
  • Events can now be used within conditional expressions to hide or show fields based on the current event.
  • You can now revoke the verification of item data via the status panel.

Bug fixes

  • Inputs in the data matrix are now correctly disabled if a user is missing edit permissions.
  • The form status selection is now properly enabled for users with verify and sign permissions.