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Version: 3.x (Current)

System Overview

Introduction​

The Overview tab summarizes the progress and key metrics for the selected system version. When you choose a system version, the tab automatically updates to show all the information tied to that version.

System version overview

KPIs​

At the core of the Overview tab, a global progress bar shows the overall completion percentage of the entities associated with the selected system version. Each Key Performance Indicator (KPI) is the ratio of correctly resolved issues to the total number of issues for that entity.

Below the global progress bar, detailed progress bars break down the completion status for each type of entity:

  • Requirements: Tracks the implementation and approval status of defined requirements.
  • Risks: Reflects the identification, assessment, and mitigation of risks.
  • Tests: Monitors the execution and success of validation and verification activities.
  • Software Items: Tracks the completion and review status of individual software components.
  • Change Requests: Shows the resolution of requested changes across the system version.

Reports​

Use the select dropdown menu directly beneath the overall progress bar to generate and download reports for the selected system version.

These reports are available as Default templates:

  • Release Note: Summarizes the key updates, features, and resolved issues in the system version.
  • SOUP Report: Details the use of all Software of Unknown Provenance (SOUP).
  • Changelogs: A folder with the changelog of each custom software component.
  • Unit Tests: Outcomes and coverage of the unit tests performed on custom software components.
  • Vulnerability Report: Summary and details of the vulnerabilities detected in the system version.
  • Software architecture Design: The high-level design of the software items, as an image.

These reports are provided as a startup package of customizable templates:

  • Release Note: Summarizes the key updates, features, and resolved issues in the system version.
  • Acceptance Test Report: Results of the acceptance testing that verifies the system against its specified requirements.
  • Verbale collaudo: The official test acceptance record (Italian compliance document).
  • Traceability Matrix: Maps the relationships between requirements, design elements, tests, and other artifacts to ensure full traceability.
  • Change Report: All changes made to the system version, including modifications, additions, and deletions.
  • Software Architectural Design Description: Describes the high-level software architecture, including components and interfaces.
  • Risk Management Report: Lists the identified risks, their assessments, and mitigation strategies.

These reports support compliance, traceability, and audit or external review.

Custom Reports​

Create additional custom reports by designing templates in the documentation engine. Once published, a template appears in the dropdown menu and can be downloaded for any system version. See the Documentation Engine.

For more about the available reports, see the dedicated section.

Suggestions​

On the right-hand side of the Overview tab, the Suggestions box lists recommendations for complying with the regulations that govern Software as a Medical Device (SaMD) development, such as IEC 62304.

Suggestions are categorized into three levels of severity:

  • Error: Critical issues that must be addressed immediately to meet compliance and avoid major risks.
  • Warning: Issues that are not critical but could lead to compliance gaps or delays if not resolved.
  • Info: Non-mandatory recommendations or observations on process efficiency and documentation quality, such as optimization opportunities or additional audit notes.