Confimedis Platform v2.23.0
Overview
| Scope | Feature |
|---|---|
| Version | v2.23.0 |
| Release date | October 3, 2025 |
| Deployed to Confimedis Cloud | — |
| Affected modules | General |
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
- General: Confimedis Assistant (Beta)
- Today, we are excited to announce and release the first beta of the Confimedis Assistant: A human-in-the-loop and privacy-first AI supporting system that can be used for different purposes across the Confimedis Platform.
- Every task results in a suggestion which needs to be manually verified and accepted by a human, visually rendered as side-by-side comparison with the current state.
- The assistant can create or edit eCRFs, extract structured medical information, or proofread and translate documents, all based on textual, image, or PDF inputs.
- Our applied AI model is hosted in the Telekom Cloud in Germany. Data is neither used for training, nor logged, analyzed, or stored. Moreover, we provide support for Gemini Nano, a small model that can run entirely offline on modern computers.
