An architecture diagram is a vital tool in various fields such as software development, system engineering, and organizational design, serving as a visual representation of the structure and components of a system. It simplifies complex systems by breaking them down into their constituent parts, illustrating how these parts interact with each other. This visual depiction aids in understanding, analyzing, and communicating the system's design and functionality, both within the team and to external personnel. Moreover, it plays a crucial role in planning, decision-making, and identifying potential issues or inefficiencies in a system, making it an indispensable part of the design and development process.

The FDA's guidance Content of Premarket Submissions for Device Software Functions gives us a look at what they'd expect to see in an architecture diagram during a regulatory submission.

Ketryx's architecture diagram module allows developers to automatically generate an architecture diagram that meets the requirements listed in this guidance and IEC 62304 - Medical device software - Software life cycle processes.

The architecture diagram is generated based on the relationships between software item specifications that have been defined in Jira, namely the parent/child relationship and the used items field. See this FAQ for more information on the differences between the two.

In Ketryx, navigate to the Architecture Diagram by clicking on the Architecture button on the left toolbar.

A parent / child relationship is represented by layers of boxes which represent the software item specification configuration item that they represent.

In this example, "Database [DS-2]" introduces two nested child specifications: "Test Data [DS-58]" and "Training Data [DS-59]".

Blue arrows represent the "used items" field from a software item specification. This arrow may be unidirectional or bidirectional depending on how you define the relationship between the items. 

In this example, "Dose Service API [DS-1]" has used items "Interference [DS-56]" and "Validation [DS-62]". 

Troubleshooting: 

Only one layer of specifications is shown

It is likely that relationships between software item specifications (Parent software items and Used items) have not yet been established. You may want to create a software item specification that provides an overview for how the software will meet a requirement and then link child requirements to the parent that you created. Additionally, you may want to utilize the Used items field to indicate software item specifications that references or calls upon another specification.