The Ketryx FDA Software Compliance Platform - Ketryx

Meet the Ketryx Platform

AI-powered lifecycle management for life science teams

The only developer-first connected lifecycle management platform built to use your preferred tooling

Specialized AI Agents:

AI across your DevTools

Ketryx AI Agents interoperate with your DevTools like Jira, GitHub, GitLab, and AWS—analyzing work as it happens and capturing compliance context automatically. Developers stay in flow while AI handles the regulatory lift.

AI-driven QMS enforcement

Ketryx AI Agents act as quality enforcers across all connected systems. They coach developers in real time, flag deviations, and automatically enforce QMS processes directly in your preferred DevTools.

AI-powered traceability

Ketryx generates a living traceability matrix—continuously mapping requirements, risks, and tests. AI Agents detect gaps, propose missing links, and suggest risk controls before auditors ever see the file.

AI-generated documentation

Ketryx automates Part 11–compliant documentation. Its AI agents draft evidence, suggest links, and auto-update files throughout your dev cycle.

AI-accelerated releases

Release safer software faster with AI Agents that draft documentation, recommend traceability links, perform change impact analysis, and automate postmarket surveillance—all while your team focuses on innovation.

Watch How Ketryx Simplifies Traceability for Regulated Products.

Orchestrate releases across dev tools
Automatically generate required documentation
Enforce your procedures across dev tools

Planning & Research

Define project scope, objectives, and gather user requirements, while conducting preliminary market and technical research.

Risk Analysis

Identify potential risks associated with the software and assess their impact on patient safety and product performance.

Design

Create detailed software architecture and design specifications, ensuring compliance with regulatory standards.

Develop

Write and compile the code based on design specifications, integrating necessary functionalities.

Deploy

Install the software on the intended hardware or platform for initial testing and use.

Test

Conduct thorough testing, including unit, integration, and system tests, to verify software functionality and reliability.

Verification & Validation

Confirm that the software meets all specified requirements and intended use through rigorous testing and evaluation.

Final Risk Analysis

Reassess risks post-development to ensure all potential hazards have been mitigated or controlled.

Release

Prepare and approve the software for market release, ensuring all regulatory and quality requirements are met.

Distribution

Distribute the software to end-users or customers, ensuring proper documentation and support are provided.

Postmarket Surveillance

Monitor the software's performance and safety in the market, gathering user feedback and addressing any issues or updates needed.