Release Notes – v1.3.0 (Portal) IFU025(02)

Summary

2025-12-17

RARE Portal v1.3.0 introduces Batch Configuration Management and a simplified payment tier model.

This release gives organisations a dedicated interface for managing calibration and configuration data at the batch level, improving traceability, auditability, and control over quantitative workflows. It also clarifies the commercial model by separating “Free” and “Paid” service levels, with feature access and audit trails enforced in the Portal.

New Features

Batch Configuration Management

• Adds a dedicated Batch Configuration Management interface in the Data Analysis section of the Portal.

• Allows users to view, manage, and apply calibration curves and configuration parameters linked to specific assay batches.

• Supports filtering and sorting batch configurations by:

  • Batch ID

  • Organisation

  • Creation date

  • Parameter deviation

• Enables key batch-level actions, including:

  • Viewing batch configuration details

  • Editing configuration parameters

  • Applying configurations to applicable assays

  • Enabling or disabling specific batch configurations

• Enhances traceability and auditability of calibration workflows by making configuration history and batch-level changes clearly visible and controllable.

Simplified Payment Tiers

• Introduces a clearer distinction between Free and Paid service tiers for the RARE Portal.

• Free tier:

  • Provides access to essential platform capabilities, including Phoenix reader configuration and core Portal access.

• Paid tier:

  • Unlocks advanced capabilities, including:

    • Batch configuration management

    • Customised reader configuration

    • Phone management

    • Reprocessing

    • Interpreter management

    • Performance reports

• Enforces feature access by tier, with:

  • Clear upgrade prompts when restricted features are accessed from a Free account.

  • Audit logging of restricted or failed actions for regulatory and commercial traceability.

Improvements to Existing Features

• Refines the Data Analysis area of the Portal to integrate Batch Configuration Management as a first-class workflow, improving navigation and discoverability for analysis and configuration tasks.

• Aligns feature gating and access control across existing Portal features with the new Free/Paid tier model, ensuring:

  • More consistent user experience when attempting advanced operations.

  • Clearer messaging around what is available to which organisations.

• Strengthens traceability and audit coverage for configuration and access-control related actions, supporting compliance with ISO 13485 and IEC 62304 by:

  • Making feature boundaries objectively verifiable.

  • Ensuring configuration changes and restricted-access attempts are auditable.

Bug Fixes

• No specific bugs are recorded for this version.

• No additional Portal defect fixes are therefore called out explicitly for v1.3.0 in these notes.

Known Issues & Limitations

• No open defects or limitations are recorded as known issues for RARE Portal v1.3.0 on the linked review page.