Confimedis Platform v2.12.0
Overview
| Scope | Feature |
|---|---|
| Version | v2.12.0 |
| Release date | June 7, 2025 |
| Deployed to Confimedis Cloud | — |
| Affected modules | Subjects |
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
- Subjects: Custom fields in subject list and table
- You can now display any form field as a custom value in the subject list and table.
- Subjects can be filtered and sorted by these custom fields.
- The default subject creation date can be hidden if desired.
- This enables use cases such as adding a custom subject status or displaying an alternative date field.
Improvements
- For fields in expressions (conditions and calculations), the event name is now shown if it’s different from the current one.
- Added custom step intervals for numeric inputs (integer and decimal), as well as for the range slider.
- The aggregated subject form status now renders more granular values instead of 20% steps.
- Numeric fields now use region-specific decimal separators in reports and exports.
Bug fixes
- Temporarily disabled the automated inactivity logout during large data imports to prevent interruptions.
- Improved the handling of conditional forms in repeating events.
- The completion progress for optional events is now shown without influencing the aggregated subject status.