Ketryx AI Agents differ from generic AI tools because they operate with the complete
context of your quality system, organization, and regulatory standards.

First, Ketryx is configured according to a company’s quality management system and processes,
converting them into a live knowledge graph, so each agent cannot take action outside of
an organization-specific, deterministic ruleset.

Second, Ketryx connects to the systems that teams use to do their work, like Jira or GitHub, giving agents a 360-degree view of requirements, code, risks, and tests. This lets them spot traceability gaps or conflicting items that point solutions can’t see.

Third, everything runs inside the Ketryx environment, meaning that the controls that enforce the ruleset that the agent must follow, the Part 11 11-compliant audit trail, and the requirement for a human in the loop are fully validated.

The Ketryx Requirement Conflict Detection AI Agent is the first validated AI agent specifically designed to support FDA-class, safety-critical work. This agent helps you detect conflict issues required to be addressed under FDA regulations for design inputs (§820.30(c)). Our experienced team ensures every validation step follows a robust, proven methodology and is audited to the same standards that medical device manufacturers use (ISO 13485, ISO 14971 and IEC 62304). We are also actively validating additional agents.

Ketryx AI Agents maintain human-in-the-loop oversight for safety-critical decision-making so that regulated teams can leverage the power of AI to generate documentation and accelerate product delivery. However, the critical decision-making remains under human purview.

Ketryx AI Agents generate audit-ready evidence and push it directly into our customers’ preferred tools like Jira. This means our customers can reduce their documentation efforts by 90% while improving quality and compliance