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Ketryx 2.0 Release

Establish milestones, implement hotfixes, and discover greater FDA cybersecurity and traceability
Erez Kaminski
August 11, 2023
May 11, 2023
5 minutes to read

Today, Ketryx, the leader in Application Lifecycle Intelligence enabling FDA-regulated software development teams to release 3 times faster, announced the release of Ketryx 2.0, which enhances the tools teams have to build safe and reliable software, focusing on efficiency, process control, and traceability. This mantra is everywhere in our practices, and this latest update is no exception. 

Between the new FDA cybersecurity guidelines, the AI/ML draft guidance, and the growing connectedness of software development with the cloud and other open source software, teams are struggling to keep up with the changes. Ketryx 2.0 aims to address these challenges by automating the most difficult parts of monitoring and documenting, streamlining your SOPs and saving your sanity. 

In this latest release, we've expanded our feature set to enable Quality teams to generate their traceability matrixes even easier while working with any QMS, and enable R&D teams to move at an even faster pace. Here's how:

  1. A transparent and powerful milestone process 
  2. Automatic architecture diagram generation and the ability to export it to a preferred format
  3. Expanded hotfixes for better change management 
  4. Greater automated test integration
  5. A more comprehensive risk control dashboard
  6. Deeper connection into CI/CD

Curated milestones for a more team-centric experience

The milestone feature is a notable addition that will have the biggest impact on your team dynamics, SOPs, and project visibility. You are able to control the speed at which your team moves by inputting project milestones to mark progress and keep every member of your team coordinated as you build. The milestone feature acts as a gate that can be based on configuration items or on another project, and once that task is complete, the gate is unlocked and you and your team can progress in the parent project.

In this update, a milestone can either be based on:

  1.  A type of configuration item (CI): If a CI is the milestone designation, this means all items need to be in a controlled state and fully approved before moving forward. 
  2. The release of another project: In the case where one project references another project as a milestone, such as a parent project with a child, all items in the child project must be fully approved, or the release is not possible and the parent project cannot move forward. 
Milestone configuration dashboard allows teams to name and define unique milestones.

The key to the milestone feature’s success is greater control and traceability. If one part of your team completes their milestone actions before another, Ketryx’s milestone system prevents further action until all requirements of the milestone are met. Once your team meets a milestone, you can then generate documentation that captures your project in its latest version, including all meeting notes, for traceability and reference. 

Worried about all the little changes that happen within a team project? Ketryx automatically notifies you of any changes made within a milestone, permitting the synchronization of development tasks to keep all milestone items true. Once this action is done, your project will have to be re-approved to unlock the milestone. 

This process eliminates the need for manual checks, saving your team time and effort, and the automatic shutdown of development enforces compliant workflows and helps you stay updated no matter what area of the platform you modify, reopen, or change, allowing your entire team to easily track progress and stay on top of changes that may affect their work. 

View all project milestones at once

Layered software architecture diagrams and easy exporting

With increasing complexity in many SaMD or SiMD, software architecture remains a crucial requirement for understanding your software development, but the construction of massive software architecture can be hard to create and track. Ketryx can now automatically generate an architecture diagram that follows the latest FDA SaMD guidance in terms of structure and styling, all based on specifications and relations data already represented in Jira. 

Ketryx’s readable, automatically generated, architecture diagram can export diagrams to, Lucidchart, and other apps, enabling teams to share and collaborate with a bird’s eye view of your software structure. 

Layered software architecture following FDA SaMD guidelines.

Patch releases for proactive change management 

Imagine you release a project version that took months to approve. You followed all the processes and milestones, generated all the documentation, ran all the tests. Then, you find one critical issue after release. CAPAs come in and everything is chaotic because how do you fix a safety-critical system as it’s running?

With the latest update, Ketryx enables a quick patch release that you can mark as a “hotfix” within your formal release. This designation sets your project into a special mode and allows you to fix issues and change selected CIs within your formal release without disrupting your workflows or documentation, maintaining your control and history. 

Ketryx’s hotfix process enables teams to take control of their change management process with little disturbance to their current tasks. 

Integration with Xray and automated tests

Ketryx now integrates with Xray, which allows users to manage tests in Jira using Xray. These tests can then be captured in Ketryx for documentation and traceability purposes. This level of connectivity allows teams to create Xray test cases, organize them in test sets, define and execute granular steps, all while automatically documenting each step and recording evidence in Ketryx.

Independently of Xray, automated builds can report test results to Ketryx through an API or a GitHub Action as well. By referencing Jira ticket numbers from automated test names or tags, Ketryx can establish the Test Case or other configuration item that each executed test is associated with.

The ability to automate testing documentation in other software improves workflows for R&D and QA, who spend time managing the test cases and processes. With this automation, they find less human error, more consistent results, faster development, and safer software.

A transparent risk control screen for proactive risk management

Ketryx’s risk control screen organizes all controls, requirements, and tests that manage risk, allowing teams to be more proactive to hazards than ever before. The table indicates the hazard level of each concern and even works in tandem with the milestone feature to identify potential risks within each configured milestone. 

This dashboard for risk controls is a critical feature for teams that need to manage risks effectively and ensure that they are meeting regulatory requirements throughout each step of the development process. If tests or approvals are missing, any member of your team knows with just a glance. With teams on the same page, prioritizing safety and risk management is faster than ever before. 

Creating a culture of quality

Ketryx strives to help others create safer and more reliable software. We believe better processes and tools lead to improved team satisfaction and, most importantly, better patient outcomes, and we look forward to hearing about our users’ experience with Ketryx 2.0. 

But don’t take my word for it. Ketryx Senior Developer Patrick Ecker summarizes the major benefit of the latest feature update: 

“This is going to save your team’s sanity.”