Introducing Agentic AI for Safety-Critical Software
AI Agents for Regulated Software Teams
Ketryx AI Agents help you enforce compliance, maintain documentation integrity, and surface traceability gaps—while keeping full control in your hands. Agents continuously scan across your connected systems to find the things humans miss, suggest improvements, and act with your approval.
The Exponential Complexity of Compliance
Why AI Is Essential
in Highly Regulated Environments
When teams work across fragmented tools, traceability breaks down fast—making it hard to connect requirements to tests, align evidence with procedures, or catch documentation gaps before an audit. The result? A higher risk of rework, audit delays, and missed compliance steps, all while draining resources through manual documentation.
Read the Blog: How People and Agents Build Regulated Products Together
30-40%
Increase in project costs when validation is required Gartner 2022
12-18%
Share of industry revenue consumed by quality assurance overhead McKinsey & Company
Your Data and Tools with the Power of AI
Specialized AI Agents for
High-Impact Compliance Work
Ketryx Agents are purpose-built, AI-powered teammates for regulated product teams. Working with knowledge of your QMS, each AI agent connects to your tools to detect issues, draft documentation, and recommend actions, always surfacing changes for human review.
Requirement Conflict Agent
Review conflicting requirements 95% faster. Automatically detects and flags conflicting requirements so you can catch issues early, avoiding costly rework and reducing compliance risk.
Redundancy Detection Agent
Identify redundancies 85% faster. Scans requirements, detects duplicate or overlapping items, and recommends fixes so that teams aren't uncovering duplication in final documentation or at the end of the release cycle.
Change Request Review Agent
Reduce rework by 80%. Verifies that every change request has all the appropriate fields filled out, flags any gaps, and suggests updates for completeness and consistency.
Test Coverage Agent
Analyze test coverage 90% faster. Scans tests and requirements to evaluate test coverage and surface gaps, so you can confirm that everything that needs a test has one.
Complaint Agent
Triage complaints 80% faster. Streamlines complaint intake, documents and categorizes complaints instantly, and flags critical signals so you can uncover quality issues early.
Anomaly Review Agent
Review anomalies 90% faster. Verifies the completeness of anomaly records in your system (like checking for root causes), flags missing evidence, and suggests updates so that critical anomalies don't get overlooked.
Human-in-the-loop control
No change ships until you approve the agent’s recommended changes
Proactive issue detection
Agents flag conflicts and gaps before audits or releases
Accelerate critical tasks
Automate specs, trace links and risk docs in minutes
Validated by Teams Who Know Compliance Best
3 of the Top 5 Medical
Device Leaders Use Ketryx
“We use Ketryx to analyze risks, find incomplete or missing risks, and trace requirements to the associated risks. Previously, this process was manual, so Ketryx gives us a repeatable quality process, saves us time, and helps us release faster while also ensuring that we have controls for all risks.”
Nicole Hollauf
Risk and Compliance Manager
Risk and Compliance Manager
10x
Faster releases
90%
Reduction in documentation time
30%
Reduction in total project costs
How It Works
A Smarter AI Workflow—
With a Human at Every Level
Ketryx AI Agents use Large Language Models (LLMs) to interpret natural language queries, retrieve information, and generate content about your software project. All interactions occur via a zero data retention endpoint, meaning data is processed in-memory only and never stored or used to train models. Agents can’t take any action without human approval.
Prompt
Ask Ketryx a question or to take action using everyday language.
AI Agents activate automatically or on demand—no manual digging required.
Analysis
Ketryx AI Agents analyze your project across all connected systems to flag issues and gaps.
Each analysis is in-depth and is different in structure based on the context of the query.
Recommendations
AI Agents provide suggestions with redlines, making it easy to understand what is being recommended.
Agents also provide suggestions on which items should be linked and which items need to be created, enabling faster, more complete traceability.
Human Review
AI Agents will never take any action; a human must review and approve every recommendation agents make.
This means that you keep your experts in control of your process while making them more efficient.
Sync
With your approval, AI agents will take action throughout your connected systems.
Agents will begin updating requirements within your systems (like Jira) and adding traceability where needed.
Take the Next Step
Ready to Simplify Regulated Software Development?
Turn compliance into an accelerator with AI-driven insights and automation.
