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Confimedis Platform v2.6.0

Overview

Scope Feature
Version v2.6.0
Release date December 6, 2024
Deployed to Confimedis Cloud —
Affected modules Reports, Users

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

  • Reports: Pie chart
    • A new pie chart can now be added to custom reports to visualize the ratio of categorical values.
    • A chart-based filter can now be deselected by simply clicking on the value again.
  • Reports: Date binning in charts
    • It’s now possible to group date values by year, month, day, or weekday in categorical charts (e.g., bar or pie charts).
    • Binned values can be used as live filters (e.g., showing subjects recruited in a specific year, month, or a combination of both).
  • Users: Role and permission matrix
    • Roles and their assigned permissions can be viewed and edited in a tabular overview for improved clarity.
    • Two new default roles were added for study nurses and data managers.

Improvements

  • The date picker now also supports the time-only data type.