Confimedis Platform v2.15.0
Overview
| Scope | Feature |
|---|---|
| Version | v2.15.0 |
| Release date | July 23, 2025 |
| Deployed to Confimedis Cloud | — |
| Affected modules | Export |
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
- Export: Queries in CDISC ODM and PDF/A exports
- Queries can now be exported to, and imported from, CDISC ODM-XML files.
- Exports include the entire history of each query, with all comments and state changes.
- For PDF/A exports, queries are added to an item’s audit table to provide a holistic overview.
Improvements
- When exporting a report table that has file columns, it’s now possible to export all included files as a directory.