T-012-029 Software Architecture Description
Object
Briefly state the objective of this document. Clarify that it supports regulatory submissions (e.g., CE marking, FDA) and explain its relevance in the software lifecycle.
Scope
Define the software product or system to which this architecture applies. Mention the version and context of deployment if relevant.
Document Overview
Abbreviations, Terms & Definitions
List and define all acronyms, technical terms, and domain-specific language used throughout the document.
Project References
Include references to related project documents: development plans, requirement specifications, lifecycle plans, etc.
Standard and Regulatory References
List applicable regulations and standards (e.g., IEC 62304, ISO 14971, ISO 81001-1, MDR Annex I). Provide the clause numbers where possible.
Conventions
Describe any formatting, color-coding, or naming conventions used for diagrams, terminology, or sections.
Architecture
Architecture Overview
Users and Environment
Describe who the end users are (e.g., clinicians, patients) and the physical or digital environments where the software operates.
Purpose and Workflow
Explain the high-level purpose of the software and outline its core workflow from start to end.
Main Functions
List the major functionalities provided by the system. Keep it high-level and aligned with user goals.
Main Interfaces
[Interface Name]
Output
Describe the data, messages, or behavior produced by the system through this interface.
Input
Describe the expected inputs received through this interface, including source, format, or trigger.
Global System Views
Connections
Explain how software modules or external systems connect (APIs, libraries, data buses, etc.).
Dataflow
Illustrate the main flows of data between components or systems. Identify key transformations or endpoints.
Multi-Patient Harm View
Describe measures to prevent harm caused by data overlap, contamination, or corruption across patients.
Updatability / Patchability View
Detail how the system will be updated in production (e.g., remote patches, validated updates).
Security Use Case View(s)
Explain at least one use case per security function (e.g., authentication, encryption, access control) with its expected behavior.
Logical Architecture Overview
Break down the system into software items (components). For each:
- Describe its purpose
- Mention any included SOUP or third-party tool
- Explain how it connects with others
Create one sub-section per software item.
Dynamic Behavior of Architecture
Describe common sequences or interaction flows between users, components, and systems. Each use case (e.g., "User starts exam") should include a short narrative or sequence diagram.
Justification of Architecture
System Architecture Capabilities
Performance
Explain how the architecture meets required performance constraints (e.g., speed, responsiveness).
User Safety
Describe architectural decisions that enhance user or patient safety (e.g., fail-safes, alerts, validation layers).
Software Security
Explain how the design prevents unauthorized access, data leaks, or abuse (e.g., encryption, access tokens).
Adaptability, Flexibility
Justify how the architecture can accommodate future changes or product variants.
Monitoring
Describe monitoring and observability mechanisms (e.g., logging, alerts, health checks).
Network Architecture Capabilities
Interoperability
Explain how the software communicates with other systems or follows interoperability standards (e.g., DICOM, HL7).
Communication Security, Data Integrity and Confidentiality
Describe how secure communications are achieved (e.g., HTTPS, TLS, data hashing, audit trails).
Risk Analysis Outputs
List any architectural modifications that resulted from the risk management process. If none, explicitly state it.
Human Factors Engineering Outputs
Summarize architecture changes influenced by usability studies or human factors analysis.
SOUP Integration
Mention which SOUPs are used and how they are integrated. Include versioning, licensing, and purpose.
Cybersecurity
Describe how cybersecurity best practices (e.g., secure boot, threat modeling, defense-in-depth) are reflected in the architecture.
6. Requirements Traceability
Link the components or architectural decisions to the relevant software requirements. You can reference a traceability matrix or summarize the mapping directly.