Introducing Ketryx Intelligence: Accelerate Product Development Safely with Generative AI

As part of our journey to make systems safe and reliable and accelerate the rate of medical innovation, we are building FDA-grade tools and processes to help life science product teams develop fast and stay compliant.

We spent the first years of Ketryx developing the formal system and infrastructure needed to deliver safety-critical products. This includes an interoperable platform that allows teams to work in the tools they already have in place and a rule-based expert system that can be validated to ensure control and quality. Along the way, we've integrated automation and AI to make it easier for regulated teams to build compliant, life-saving innovations faster. These building blocks form the basis of everything we build at Ketryx. 

Now, we're unveiling a fuller picture of what Ketryx will become: a way for people and AI to collaborate on building regulated products together, safely. After years of using Ketryx's AI functionality internally to accelerate our own development, we are rolling out the first of these capabilities for use by regulated teams.

Life science companies spend weeks or months before every release doing documentation. But instead of using AI to accelerate product development and documentation, many companies instead hire more and more people, adding additional layers of complexity and cost to slow-moving projects. The resulting documents are often thousands of pages long, in addition to thousands of pages of complex QMS documents that inform the process. As a result, growing teams of people are left with a lack of clarity on what they need to do next.

When used in a risk-based way with layers of human approval, AI can significantly accelerate these drawn-out processes and help regulated teams get products to market faster.

Ketryx Intelligence is a risk-based generative AI framework with fine-grained output control and human-in-the-loop approval processes built to safely streamline and accelerate your regulated product delivery. By automating key tasks, simplifying change management, and ensuring consistency and compliance, Ketryx Intelligence enables regulated teams to develop safer software, faster, while maintaining human oversight of critical decisions.

QMS querying

Teams no longer need to memorize long, complex QMS documentation. Ketryx Intelligence reduces dependency on manual searches and training by helping you easily query your QMS.

• Ketryx Intelligence uses advanced Retrieval Augmented Generation (RAG) technology to help you navigate your QMS. 
• Rather than just searching for keywords, Ketryx Intelligence understands concepts and context, finding relevant information even when exact terms don’t match. 
• Ask questions about compliance requirements to search your QMS--Ketryx Intelligence provides responses that include citations to specific QMS documents, helping you verify the source of each answer.

Try these prompts:

• When and how can I defer an anomaly according to our policies?
• What's the process for an urgent deployment?
• Can you summarize the work instruction for test executions?

Smart filtering commands

KI can translate natural language queries into Ketryx Query Language (KQL) to help you find and filter items based on specific criteria without having to learn KQL. Using AI-based natural language understanding, it converts your natural questions into precise database queries.

Try these prompts:

• "Show me all requirements that are not yet approved"
• "Find software items that fulfill requirements"
• "Show me test cases in the test plan for version 1.0"

Test case generation

Save time on the tedious manual creation of test cases and get to market faster. 

• Use prompts to create a test with Ketryx Intelligence. 
• Generate and refine the draft, keeping a human in the loop.
• Once ready, the test will be automatically synced with systems like Jira.
• Ask Ketryx AI to suggest improvements to existing items to increase quality and accuracy. 

Try these prompts: 

• “Create a detailed test case for KP-2040”

Traceability suggestions 

KI can help suggest traceability relationships between items by using the 🪄 Suggest button next to relation fields. This feature can help with:

• Identifying affected items for Change Requests
• Finding parent requirements for new Requirements
• Suggesting related test cases
• Identifying potential risks and controls

Item edit suggestions

KI can suggest edits to existing items, like requirements and specifications, to ensure that these items are precise and compliant. This functionality not only increases the quality of your requirements and other configuration items but also saves your team time on tedious manual reviews. KI suggests improvements, and the user reviews the improvements before applying the changes. 

Try these prompts: 

• “Improve the description section of KP-123”
• “Make sure KP-123 is compliant with ISO 14971”

Intelligent content search

KI uses Retrieval Augmented Generation (RAG) technology to analyze your project's content and find relevant matches, even when exact criteria aren't known. This means it can understand context and find items based on concepts and meaning rather than just matching keywords or fields.

Try these prompts:

• "Do we have requirements that talk about bluetooth?"
• "Show me all specs relating to cybersecurity"
• "Someone at the meeting mentioned depth for water resistance. Can you find the relevant requirement?"

Ketryx Intelligence is designed to transform how life science teams manage their regulated development process. By automating time-consuming tasks, automating traceability, and simplifying complex queries, KI empowers teams to focus on innovation while maintaining the highest standards of safety and quality. With Ketryx Intelligence, you can develop safer software, faster—unlocking new possibilities for your organization and the patients you serve.

Try these features now through a free trial of Ketryx.