Confimedis Platform v2.13.0
Overview
| Scope | Feature |
|---|---|
| Version | v2.13.0 |
| Release date | June 26, 2025 |
| Deployed to Confimedis Cloud | — |
| Affected modules | 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
- Documents: Redesigned documents
- The document editor now supports text alignment and tables.
- A new fixed inline menu is always reachable at the top of a draft document.
- Documents can now be exported to PDF/A, including text alignment, tables, images, lists, and more.
- Documents: Expressions in documents
- It’s now possible to add arbitrary expressions to documents and descriptive texts.
- Expressions can pipe in previously entered (clinical) data or perform calculations.
- New functions in expressions help to format dates and numbers into localized values.
- Conditional sections in documents can be hidden based on previous inputs.
Improvements
- Custom fields are now rendered for events and forms when available.
- In addition to fields, sections, forms, and visits, study event groups can now be re-ordered via drag-and-drop.