Regulatory Compliance IFU027(01)

What RARE Compliance Features do

RARE is developed under an electronic Quality Management System (eQMS) certified to ISO 13485:2016, and our software development lifecycle aligns with IEC 62304 for medical device software. This means the RARE platform is built and maintained using controlled, auditable processes that are familiar to IVD and medical device regulators, giving you confidence that it can support use in regulated workflows.

RARE provides robust tools to help you:

• Ensure all assay data, configurations, and results are securely stored and traceable.

• Maintain a complete audit trail for every action, including data uploads, configuration changes, and result interpretations.

• Track version control for datasets, batch and classifier configurations, and interpreter logic.

• Achieve full traceability from results back to calibrations, configurations, and input data, and forward into the assay and reader configurations you choose to take into verification and validation.

• Explore “what if” scenarios to support assay and reader app development, optimisation, validation, and QC investigations.

• Export data and audit logs for external review or regulatory submission.

These features help you demonstrate control over your digital QC and validation processes, and provide confidence in the integrity of your assay results.

How RARE supports your end product

RARE is designed to give you traceability not only for day-to-day data handling, but across the lifecycle of your assay and reader development:

Assay development and optimisation

Use RARE to collect and analyse data from feasibility through development and optimisation, with full versioning of methods, classifiers, and configurations. This lets you show how your assay has evolved, and on what evidence key decisions were based.

Reader specification for market use

By controlling and recording the interpreter logic, thresholds, and configuration sets used in your analysis, RARE helps you derive a clear, auditable reader specification that can be taken into verification, validation, and ultimately market release.

End-to-end traceability

From the moment data is captured in the mobile app through to aggregated analysis, reporting, and final reader settings, each step is logged and traceable, supporting your technical file and design history documentation.

This end-to-end view means you can use RARE as a tool within your own quality system to support both assay optimisation and the creation of a reader specification intended for use in the market.

Where to Find Compliance Features

• Web Portal: Most compliance features (audit logs, version history, export tools, traceability views) are available in the RARE web portal.

• Mobile App: Core data capture and authentication features are supported; some advanced compliance tools (e.g., full audit log export, traceability matrix) are web-only.

• Access: What you can see and do depends on your user role and your organization’s subscription.

Key Concepts

• Audit Trail: A complete, time-stamped record of all actions taken in the system, including who did what and when.

• Version Control: Every change to datasets, configurations, or interpreter logic is tracked, with previous versions preserved for review.

• Data Integrity: All data is stored securely, with checks to prevent unauthorized changes or deletions.

• Traceability: The ability to link every result back to its source data, calibration, configuration, and user actions.

• What If Scenarios: Tools that let you reprocess data with different configurations to support assay development and validation.

• Export: Downloadable reports and logs for regulatory submissions or internal audits.

After You’ve Used These Features

Once you’ve set up and used the compliance features in RARE, you can rely on the following:

• Reviewable history: All key actions are logged and available for review through Audit Logs and Version History, supporting internal reviews and external audits.

• End-to-end traceability: Every reported result can be traced back to its source data, calibrations, configurations, and user actions.

• Preserved data integrity: Original data is not overwritten; changes create new versions, so you always retain a complete, auditable record.

• Regulatory readiness: You can export logs, version histories, and traceability reports as evidence for audits, inspections, or regulatory submissions.

Referencing RARE in your regulatory documentation

You may wish to reference the RARE platform in your own technical file, design history file, or other regulatory documentation.

For example, you could describe it in terms similar to the following:

“The RARE platform is used as a supporting software tool within our quality management system for the collection, management, analysis, and traceable storage of assay data. RARE is developed and maintained under an electronic Quality Management System (eQMS) certified to ISO 13485:2016, with a software development lifecycle aligned to IEC 62304 for medical device software.

Within our process, RARE provides end‑to‑end traceability from raw data capture through to analysis outputs and the reader configuration intended for market use. It supports version control of datasets and configurations, complete audit trails for key actions, and exportable logs that are used as objective evidence in verification, validation, and ongoing performance monitoring.”

You should adapt this wording to match your own procedures, document structure, and regulatory strategy.

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