Confimedis Platform v2.21.0
Overview
| Scope | Feature |
|---|---|
| Version | v2.21.0 |
| Release date | September 10, 2025 |
| Deployed to Confimedis Cloud | — |
| Affected modules | General, Documents |
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: Example project
- The system now comes with a comprehensive, multilingual example project to explore many of its features in a realistic environment.
- We added the following events and visits: Informed consent, Adverse events, Baseline, Follow-up, and Unscheduled visit.
- We integrated the standardized SF-36 and WHOQOL-BREF forms, including score calculation.
- All forms are available in English and German.
- Furthermore, the example project includes complex field validation rules (date not in the future, date not before another date, durations in hh:mm, …), conditional elements (fields, sections, and forms), repeating elements (sections, forms, and visits), data matrices, calculated fields, informed consent documents, and much more.
- To view the example project, visit our sandbox at app.openedc.health and choose Options → Example Project on the welcome screen.
- Documents: Documents via email
- You can now send any document via email to your team members or study participants.
- This makes it easy to distribute important information like reminders or announcements in a timely manner.
- For each email, the subject, language, an optional redirect button, and the list of recipients can be individually configured.
Improvements
- Render translated expressions in descriptive texts in the currently selected language of a multilingual form instead of the app language.
- Improve the position of the range slider value when the field has a description and allow calculating it with an expression.
- Enhance spacing and layout in PDF/A exports for descriptive texts and documents with complex HTML content like nested lists.
- The CDISC ODM exporter and importer now support missing reasons and validation states for individual item data values.
Bug fixes
- Solved an issue where saving a form temporarily as incomplete would not work when a mandatory field in a data matrix was unanswered.