Ketryx 2.11

Ketryx version 2.11 is here, bringing powerful new features in traceability, security, and control for life sciences teams. This release underscores our commitment to helping teams work fast and stay compliant through postmarket cybersecurity vulnerability management, easier traceability in Jira, and flexible RTM configurations. The introduction of item baseline locking and an enhanced graph page support your team as you perform variant management.

Vulnerability notifications

The FDA's recent cybersecurity guidance emphasizes the importance of vulnerability management throughout the TPLC. Postmarket vulnerability monitoring (i.e. for live versions) is a vital part of ensuring the safety of a device from a cybersecurity perspective.

As a result, quality managers are frequently responsible for monitoring the cybersecurity vulnerability profile of released versions and responding to any new vulnerabilities. In order to make it easier for quality managers to manage cybersecurity risk, Ketryx users will now be notified by email about new vulnerabilities for already-released versions of their product. 

Users can now mark versions as “active” (indicating that they are already in the field), “inactive” (no longer in use), or “automatic” (meaning that the latest released version is active automatically until a new version is released). Email notifications will alert users of new vulnerabilities reported against active and automatic versions, and will include which project and version may contain the vulnerability. Users can click the link in the email to be directed to the relevant page in Ketryx, where they can perform an assessment and take further action to mitigate the vulnerability. Users will continue to receive email notifications for the projects they are currently working on. 

Jira traceability widget improvements

Ketryx users can now manage traceability relationships from the Jira traceability widget, expanding the ability to build traceability directly in systems of work like Jira. 

Users can now do the following from the Jira traceability widget: 

• Create or remove relations from items in Jira to Git-based items, dependencies, and other projects without impacting fields in Jira
• Create and/or connect multiple related items, including reverse relations 
• See “siblings” from the same parent item 
• See AI-suggested traceability relationships 

Users will also notice changes to the UI, including the display of many associated items and a stricter left-to-right layout (from design inputs to design outputs).

Learn more in the documentation.

Predefined RTM configurations

Ketryx users can now maintain multiple RTM configurations and can choose which one they want to see on the Traceability page at any time. This allows users to define different RTM configurations for different use cases, and to switch between different RTM configurations quickly and easily. For example: 

• In the context of variant management, a user may want different RTM configurations in a project to analyze the conformance to different requirements from different regions, standards, or variants. 
• A user may create a new RTM configuration focused on anomalies in order to see if all critical anomalies have CAPAs that are traced to test cases. 
• A user may want to see the standard V-model to check for gaps in traceability coverage.
• A user may want to see if all change requests trace to at least one new or changed item.
• A user may want to define a custom threat model and see the traceability relationships for that model with cyber risks.

Users can navigate to the Traceability page to select their preferred view from the dropdown menu. 

For each configuration, the user can decide whether its traceability checks should be enforced as release gates or not. The checklist on the Release page will also reflect a traceability check for all enforced RTM configurations. 

Users can access this functionality through the Advanced Settings page, where they’ll see the field “Additional Traceability Configurations.” The original Traceability configuration will be listed as “Default.” 

Develop multiple systems in parallel through item variant management

To provide greater control over release-ready items and avoid “future-bound” updates from affecting completed documentation, Ketryx 2.11 introduces item baseline locking.

• Lock Records for Release: 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. 

• Pre-Release Control: Lock items as soon as they’re ready for a milestone, before generating documents. This maintains a controlled state for release items, even as work begins on subsequent releases.

• Flexible Lock Management: Easily unlock or adjust locked items as needed. For instance, you can “move the lock” to a particular record if further adjustments are necessary, ensuring maximum flexibility while avoiding unwanted updates. With this feature, when users are asked to modify items in a release but not to submit a new version, they can re-open the release, lock the items (i.e., take a snapshot), and re-do the release.

• Enhanced Document Stability: Generate documents based on locked records, ensuring that future Jira updates won’t alter your release documents or impact item control states. 

Use Cases Addressed:

• Controlled Documentation: Customers frequently requested this feature to ensure that completed documentation isn’t disrupted by ongoing changes in Jira.
• Snapshot Capabilities: Take a snapshot of the system at a given time to preserve item states for versioning, avoiding the need to regenerate documents due to unintended changes.
• Controlled Release Adjustments: If modifications are requested without creating a new version, users can reopen the release, lock items to the correct records, and generate new documents without altering the controlled state.

Enhanced Graph Page with AI Assistant Simplifies Complex Systems of Systems

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. Users can now manage, query, and control the graph with Ketryx Intelligence. For example, you can ask, “Show me all my tests for my AI subsystem” or “Show me all my hardware specifications and their corresponding tests” and it will populate the graph with your query. 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. This change also reduces the duplication of items through the ability to see both granular and high-level views of all items in your project, allowing you to quickly find what you’re looking for and know what work to prioritize. 

The new features in Ketryx 2.11 help life sciences teams achieve both speed and compliance in their software development processes. We’re excited to see how these new features help you save time, reduce risks, and bring safer products to market. For more details on how to maximize the benefits of these updates, check out the full documentation or reach out to our team.