Release Notes
Reference library for Ketryx release notes
2.13
Regulated teams around the world trust Ketryx to streamline compliance with IEC 62304, ISO 13485, and ISO 14971—automating traceability, documentation, and validation so they can move faster while improving quality. With Ketryx 2.13, we’re doubling down on our commitment to helping teams release safety-critical products at speed and at scale.
Ketryx 2.13 reflects our continued investment in agentic AI, configurability, and performance. This version introduces document generation speed improvements with up to 98% faster performance. We’ve also added extended research capabilities to the AI Assistant, a validated complaint classification AI agent, custom relations, a read-only guest role, and vulnerability rescoring.
Document Generation Speed Improvements
Working with enterprise-scale data is complex. Our customers use Ketryx as their system of record for tens of thousands of configuration items across Jira, GitHub, and other connected systems. Release faster with our more powerful document generation engine. Complex documents with images and intricate relationship graphs now generate up to 98% faster, so teams can generate documentation faster from the work done in connected systems.
AI Assistant Extended Mode
Ketryx AI Assistant now includes Extended Mode with streaming functionality. Extended Mode enables complex research tasks and the new streaming feature provides real-time visibility into the AI’s research process, so you can course-correct if needed. Ask complex questions about your system and watch the AI work through comprehensive analysis in real-time.
Learn more about Extended Mode in the documentation and watch a quick demo video to see this new feature in action.
AI-Powered Complaint Classification and Quality Review
The Complaint Agent is Ketryx’s newest validated AI agent. This ready-to-use agent automatically analyzes complaint configuration items to identify adverse events and classify complaints into categories based on severity. This agent accelerates complaint processing so you can triage complaints and resolve potential safety issues faster.
Learn more about the Complaint Agent in the documentation and watch a quick demo video to see the agent in action.
Enhanced Configuration: Custom Relations and Traceability
Ketryx users can now trace any configuration item—including custom items and documents—to any other item across their systems. This powerful generalization enables you to link cybersecurity risks to safety risks, connect any item type (like a CAPA) to documents, trace impact assessments to custom items, or create entirely custom traceability frameworks. Documents and custom items now integrate seamlessly with your quality management workflows.
Learn more about configuring documents as configuration items and setting up custom relations in the product documentation, or watch this quick video to see the new feature in action.
Risk Management Upgrade
Ketryx now lets you define multiple risk types with their own unique workflows. Users can now create separate item types for cybersecurity risks, safety risks, or any other risk category, each with custom fields and configurations. All custom risk types automatically appear on the Risk Management screen, inherit standard risk relationships like "introduces risk" and "is risk-controlled by," and appear in your trace matrix. This increased flexibility enables your team to manage various risk types with the power of integrated risk management. Contact your Client Operations Manager to learn more about how to utilize this feature.
Learn more about custom risk item types to enhance your risk management configuration.
Introduction of a Read-Only Guest Role
Expand your team's access to Ketryx with the new Guest Role with read-only permissions. This feature lets teams add users who can view data across the entire connected system without editing capabilities, preventing users with read-only access from modifying any data. The Guest role is perfect for staff who need context without editing or external auditors requiring system access. Organization owners can now invite guests via invitation links, view Guest status on the Members page, and export reports showing permissions for each user. This change addresses both internal organizational needs and external audit requirements while maintaining data integrity.
Learn more about adding users as Guests in the documentation.
API Enhancements
Ketryx expands our REST API endpoints to expose external item IDs and approval groups for better integration with external tools, such as dashboarding tools. Users can now receive messages with direct links to both the originating system and Ketryx, enabling uninterrupted data flow between Ketryx and external tools while maintaining traceability and compliance.
Learn more about the Group API and Item API in the documentation.
Vulnerability Rescoring with Built-In CVSS Calculator
Ketryx now includes a built-in CVSS calculator that mirrors the FIRST.org standard, supporting both CVSS v3.1 and v4.0 and eliminating the need for manual spreadsheet-based workflows. Users can rescore individual or multiple vulnerabilities simultaneously with an interactive interface featuring real-time score updates, side-by-side original versus rescored value comparisons, and contextual tooltips explaining each metric (exploit code maturity, remediation level, environmental factors). The calculator intelligently handles base metrics (locked by default), temporal, and environmental metrics tailored to your context. All rescoring actions are tracked in an audit trail so you can accurately assess vulnerability risk based on implemented controls while maintaining full traceability.
Learn more about vulnerability rescoring in the documentation.
2.12
We're excited to announce the release of Ketryx 2.12, expanding users’ ability to collaborate across tools, manage vulnerabilities, and accelerate releases while maintaining compliance. This release includes a validated integration with Google Workspace for collaborative editing, enhanced vulnerability management, updates to the AI assistant, and performance improvements. These improvements help regulated teams move faster while maintaining compliance with standards like IEC 62304, ISO 13485, and ISO 14971.
Google Docs Integration
R&D and Quality teams work closely together to finalize release documentation, often collaborating on documents and spreadsheets in Google Workspace. Ketryx’s new validated integration with Google Workspace makes it easier than ever for regulated teams to share and collaboratively edit release documents. We are continuing work to extend this integration to also work with other types of documents (in addition to release documents). To enable this integration, set up your Google Workspace credentials in the Organization > Connections settings page. Learn more here.
AI Assistant
You'll notice improvements to the design of the AI assistant located in the sidebar of the Ketryx platform, which provides a powerful way to interact with Ketryx as you're working. Use the AI assistant to ask questions about your QMS, generate test cases, filter requirements, and automate tedious tasks, while always keeping a human in the loop. Consider trying one of these prompts:
"Show me all requirements that are not yet approved"
"Help me structure a template based on this existing specification document"
"Create a detailed test case for [requirement]"
"Create risk items that may result from these requirements"
Enhanced Vulnerability Management
Improvements to vulnerability management in Ketryx support robust postmarket surveillance processes and strengthen the cybersecurity posture of your organization, in light of regulations like the EU Cyber Resilience Act and recent FDA cybersecurity guidance. Vulnerability impact assessments can now behave like standard configuration items and appear on the All items page. This enables adding custom fields and relations to the vulnerability impact assessments to align with your organization’s cybersecurity management process. Like other configuration items in Ketryx, you can now reference vulnerability impact assessments across multiple projects (cross-project referencing) to support centralized vulnerability management and traceability between complex systems of systems. Learn more here.
Comments in Ketryx
Approvals depend on clear communication, and comments act as an integral part of collaborative systems. The ability to post a comment directly on items provides context and supports stronger collaboration, especially during the approval process of items such as vulnerabilities, which are managed outside project management tools like Jira. Comment and rejection ability in Ketryx keeps your communication centralized and documented, so you can easily see the history of each item and how it has progressed. This makes it easier to track decisions and speeds up review cycles across teams. Learn more here.
Performance
As we continue to onboard enterprise customers with a high level of complexity in their projects, we continue to focus on improving the performance of Ketryx, making page load speeds more than three times as fast and bringing down the typical page load time to under 3 seconds. This performance improvement allows users to work more efficiently in Ketryx, to manage large amounts of complex data, and to release faster.
2.11
Read release notes here.
2.10
We’re excited to announce the release of Ketryx Version 2.10, with important updates including expanded integrations and improved visibility of complex systems.
Item Variant Management: Baseline Locking
To provide greater control over release-ready items and avoid “future-bound” updates from affecting completed documentation, Ketryx 2.10 introduces item baseline locking. This functionality enables teams to lock items for a specific version of their project so they can start working on future releases. This “snapshot” prevents future changes from affecting documents for that release, creating stable and controlled item states.
See how it works in this quick video!
TestRail Integration
Ketryx 2.10 introduces a robust integration with TestRail, one of the leading tools for test case creation, management, and execution. With TestRail integration, Ketryx users can now seamlessly trace test cases directly to Ketryx items, creating a connected view of testing and validation data.
Enhanced Graph Page
The Architecture page is now the Graph page, allowing users to view and interact directly with the data in their traceability matrix in a graph form and use AI to create hyper-specific filters. This change enhances the user’s ability to to visualize complex relationships between configuration items and structures, including systems of systems, and saves the user time on navigating complex data visualizations.
2.9
Read release notes here.
2.8
Read release notes here.
2.7
Read release notes here.
2.6
Read release notes here.
2.5
Read release notes here.
2.0
Read release notes here.
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