Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams

One of the biggest challenges we see regulated teams face is coordinating work across systems. Systems engineers and product marketing often use a dedicated tool to manage requirements and system-level validation activities, while their software teams rely on other tools like Azure DevOps (ADO) to manage their software development lifecycle (SDLC) and source code. Having work fragmented across multiple platforms creates major challenges in real-time visibility, end-to-end traceability, documentation, and adherence to QMS processes.

That’s why we built a native integration with ADO. Our new integration gives teams real-time visibility into all aspects of their product development lifecycle that are currently managed in Azure DevOps, enabling seamless QMS enforcement and traceability without having to leave ADO. With Ketryx, you can now transform ADO into a 62304-compliant environment with automated traceability, integrated risk management, and instant evidence generation. 

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Why Integrate with ADO?

We frequently talk to teams who use Azure DevOps as their system for managing source code, running test pipelines, and tracking work items. However, we found that many of them were running into the same problems:

• Manual effort to link requirements, code, and tests
• Siloed risk management processes
• Cumbersome documentation processes

Some teams try to solve these problems with third-party extensions, but these often come with significant drawbacks. They require ongoing maintenance to stay compatible with ADO updates, frequently break, require regular validation, and may not scale well for large amounts of data. Plus, it’s tough to integrate them with other systems, like risk management tools. 

In light of these problems, we set out to build a validated integration with ADO that would provide automated traceability, automated documentation, integrated risk management, and 62304 compliance while allowing teams to work directly in ADO (instead of context-switching to use yet another platform). 

Making ADO Work for Regulated Teams

Here’s how Ketryx’s integration with ADO solves common gaps in traceability, risk management, and documentation. 

Automated Traceability Replaces Manual Linking

For regulated teams, every code change must be mapped to requirements, risks, and test cases. We found that many teams using ADO were doing this process manually through links, a process that was both inefficient and prone to error.

Ketryx’s integration with ADO automates traceability so that you can easily identify traceability breaks and create links between items directly in ADO.

• Every requirement, test, and change is automatically linked, eliminating manual traceability tasks.
• The traceability matrix can be fully customized to match each team’s workflow: choose your rows and columns and watch the items flow in from ADO.
• Configurable checks identify traceability gaps in real time to ensure compliance.
• A local traceability widget embedded in ADO provides an accurate view of traceability between items—without having to leave ADO.

Seamless Risk Management for TPLC Control

Teams using ADO told us that their risk management process was disconnected from their software development process, leaving them with uncontrolled risks.

Ketryx’s integration with ADO integrates risk management for a seamless experience, embedding risk-based engineering controls directly into ADO. 

• Teams get true many-to-many risk relationships and automated risk tracing directly within ADO.
• AI-driven risk analysis surfaces mitigations that need to be linked and validated.
• Risk-based engineering controls ensure that changes impacting risk are reviewed and approved before release.

Audit-Ready Documentation, Faster

Every day we hear stories of documentation requiring tedious manual effort. For example, teams working in ADO tell us they have to download their documentation in batches, which slows releases and increases audit risk.

Ketryx’s integration with ADO generates evidence as artifacts directly from the work you’re already doing in ADO, no additional steps required. As a result: 

• Teams can instantly generate DHF documents, trace reports, and risk matrices from ADO.
• QA/RA teams can enforce their QMS directly in ADO so that every change is tracked, approved, and Part 11-compliant.
• Fast document generation scales as the complexity of your projects increases. 

How Ketryx Integrates with ADO

Here’s what teams can do today when they connect Ketryx to ADO. 

When working in ADO:  

• Create and manage specifications, tests, and other configuration items directly through ADO and see all updates reflected in Ketryx in real time. 
• See traceability built into ADO to understand how ADO work items connect to requirements, tests, and risks regardless of the system they live in. Trace source code changes to requirements in ADO, with traceability reflected in both ADO and Ketryx. 
• Trace ADO items to other systems of work like Jama, Polarion, and Git-based repositories like Azure Repos, Bitbucket, GitHub, and Gitlab. 

When working in Ketryx: 

• View, manage, and filter ADO work items directly within Ketryx on the All Items screen, Traceability screen, and Risk Management screen.
• Run structured KQL queries to search for ADO work items on the All Items and Traceability screens in Ketryx, as well as in document templates.
• Define custom configuration items to align ADO work items with IEC 62304 and configure how data in ADO maps to Ketryx, including item types, fields, and relation types. 
• Use ADO items as risk controls on the “Edit risk” screen in Ketryx, marking those items as risk controls that are visible throughout Ketryx. 

See It in Action: Join Our Webinar

To showcase how teams can leverage ADO for IEC 62304 compliance and AI/ML-enabled software development, we’re hosting a free webinar: ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps.

📅 Date: April 1, 2025
🕒 Time: 11am ET
🔗 Register Now

Get Started with the ADO Integration

Connecting Ketryx with ADO is simple. Head to the Connections page in Ketryx or talk to your Client Operations Manager to set up your integration and start experiencing seamless traceability today.

Want to see it in action? Schedule a demo and let our team show you how Ketryx and ADO work together to streamline compliance and accelerate development.

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