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Confimedis Platform v1.8.0

Overview

Scope Feature
Version v1.8.0
Release date July 23, 2024
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: End-to-end encryption for clinical data
    • Text, date, and signature fields now support end-to-end encryption for protecting personally identifiable information.
    • The encryption uses the PRF extension for Passkeys, enabling biometric encryption via Touch ID, Face ID, or Windows Hello.
    • A hybrid encryption algorithm uses asymmetric and symmetric primitives from the Web Crypto API (RSA-OAEP and AES-GCM), supporting end-to-end encrypted survey and participant data via a public project key.
    • Encrypted data can be viewed after authentication within forms, reports, and the audit trail.

Improvements

  • File uploads can now be viewed and downloaded from the audit trail.