Introducing Traceability in GitHub for Medical Software Development

TL;DR

This paper introduces the approach that adds traceability capabilities to GitHub, so that the developers can act like they normally do in GitHub context but produce the documentation needed by the regulatory purposes in the process.

Abstract

Assuring traceability from requirements to implementation is a key element when developing safety critical software systems. Traditionally, this traceability is ensured by a waterfall-like process, where phases follow each other, and tracing between different phases can be managed. However, new software development paradigms, such as continuous software engineering and DevOps, which encourage a steady stream of new features, committed by developers in a seemingly uncontrolled fashion in terms of former phasing, challenge this view. In this paper, we introduce our approach that adds traceability capabilities to GitHub, so that the developers can act like they normally do in GitHub context but produce the documentation needed by the regulatory purposes in the process.

Figures (6)

• Figure 1: Application of design controls to waterfall design process fda-design-control
• Figure 2: System and software development design control activities
• Figure 3: Traceability information model
• Figure 4: GitHub rendering of an issue containing requirement relationship metadata
• Figure 5: GitHub rendering of an issue containing sub-requirements