GxP for SaaS and AI
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.
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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 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.
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
Automatic Process Control
- Guided Change Control
- Automatically generate all design control documents, testing reports, and other required artifacts
- Compliant-by-Design Workflows
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
"The only developer first FDA-grade software platform."
Head of Software Development, Fortune 500 Pharmaceutical Company
Get started building software in minutes, not months.
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