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Confimedis Platform v2.1.0

Overview

Scope Feature
Version v2.1.0
Release date September 4, 2024
Deployed to Confimedis Cloud —
Affected modules Forms

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

  • Forms: Pattern matching
    • For fields with a text data type, a regular expression can be specified to constrain the data input.

Improvements

  • Mandatory fields are now clearly labeled in the PDF export.
  • Added support for the datetime data type in a data matrix.
  • Data matrices are now validated on input and on submit.
  • Added abs, date, left, and right functions to the expression parser.

Bug fixes

  • Added a missing project field to the compound key path.
  • The status for forms with multiple sections is now aggregated properly.
  • For autocompletions in expressions, the field list will now be correctly returned for items that do not have a codelist.