# AI for Life Sciences

## **Build risk-based GxP computer systems**

Reduce the complexity, time, and cost of building GAMP 5 validated applications. Automatically generate user requirements, testing plans, and any report you need, directly from your systems of work.

[Get started](https://app.ketryx.com/auth/signup?callbackUrl=https%3A%2F%2Fapp.ketryx.com)

[Watch 21 CFR Part 11 Webinar](https://www.ketryx.com/learn/webinars/using-a-risk-based-approach-to-comply-with-fda)

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Capabilities

## **Focus on Innovating Your AI/ML-Enabled Product**

Reduce the time spent on documentation to focus on product impact. All too often, software developers new to safety-critical environments struggle to integrate modern software development methodology with the documentation required to ensure patient safety and regulatory compliance.

### Generate Documentation

### End-to-End Traceability

### Automate Process Compliance

## The Benefits of Ketryx

Designed to increase developer productivity and reduce quality overhead with built-in compliance, Ketryx integrates common development tools like [Jira](https://www.ketryx.com/use-case/gxp#) or GitHub into a single traceable Software Development Lifecycle.

- Accelerate speed of development with our streamlined, end-to-end SDLC
- Streamline Part 11-compliance across your IT systems with a single source of truth
- Manage everything from requirements to test cases in one place
- Reduce developer friction and remove waste with embedded risk analysis

Capabilities

## Higher productivity. Greater control.

Connect IT systems, collect evidence, and empower your development team to build safe and reliable software applications with ease

### Automatic Evidence Generation

- Automatically generate Part 11-compliant evidence directly from Jira and other dev tools
- Automatically generate all FDA-required evidence with a single click
- All work history is automatically generated, stored, retrievable, and immutable ensuring audit-ready evidence.

[Learn more](https://www.ketryx.com/use-case/gxp#)

### Continuous System Visibility

- Connect your disparate IT systems into a single validated SDLC
- Ensure all configuration items, software dependencies, and cloud services are validated, up to date, and approved
- Compliant with 21 CFR Part 11, ISO 13485, ISO 9001, GAMP5 and other relevant FDA guidances

[See integrations](https://www.ketryx.com/use-case/gxp#)

### Automatic Process Control

- Guided Change Control
- Automatically generate all design control documents, testing reports, and other required artifacts
- Compliant-by-Design Workflows

[Explore the Jira Connector](https://www.ketryx.com/use-case/gxp#)

### Microservice Architecture Support

- Separate services into their own projects and cross-trace between them
- Version your services at different cadences and still maintain your design control
- Aggregate different services into a single set of design controls automatically

[How Ketryx supports microservices](https://www.ketryx.com/use-case/gxp#)

> "The only developer first FDA-grade software platform."

Head of Software Development, Fortune 500 Pharmaceutical Company

Are You Building Medical Software?

## Get started building software in minutes, not months.

[Book a demo](https://www.ketryx.com/use-case/gxp#)

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