| Scope | Maintenance |
|---|---|
| Version | v3.19.2 |
| Release date | November 10, 2026 |
| Deployed to Confimedis Cloud | November 12, 2026 |
| Affected modules | Forms, Documents, General, Subjects, Users |
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.
Recommended action on your side
No action requiredNote from Confimedis on version 3.19.2
The changes concern optional functions of the form editor and minor fixes during data entry, so that no behavior that running studies rely on changes and no PQ test item is affected.