Use modern dev tools like Jira when you choose Ketryx over Jama
- Enforce your standard operating procedures in your existing dev tools
- Generate your DHF directly from your source systems
- Empower your developers with their favorite tools below
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Automated and traceable
Regulated software lifecycle management
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Create FDA-grade Software
- Start developing in minutes
- Use pre-built GxP Development Infrastructure
- Remove non-value add documentation work
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Software Development and Traceability
- End-to-end traceability using your favorite tools
- Continues traceability compliance visibility
- Remove non-value add testing
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Generate Submission
- Ad-hoc submission generation documentation generation
- Maintain the flexibility of decentralized software development with the structure required for medical products
- Save time and effort with compliant-by-design workflows
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Continuous Configuration Management
- Assure regulated products are configured, safe, and reliable.
- Detailed audit-ready configuration
- Streamline product testing and release
How can Ketryx help?
Requirements Management
Manage requirements individually or as a group using the development tools you know best.
Development Management
Manage IEC 62304 compliant-by-design development workflows with pre-built guard rails
Configuration Management
Make sure your application (SOUP) and cloud configuration meet FDA standards.
Testing & QA
Ingrain Verification and Validation (V&V) into your software lifecycle. Track all phases of testing in a single simple-to-use dashboard.
Build & Release Management
We help to reduce cost, time to market, non-value added work, and turnover among regulated development teams.
Post-Market Surveillance
Process customer feedback and complaints through a risk-based approach. Connect problem reports and change requests directly to your software lifecycle.
Change Control Management
Automate change control processes and easily generate submission documents. Trace changes across the software lifecycle and reduce your testing overhead.
Audit & Metrics
Guided on-site and remote audits using dashboards designed specifically for medical software audit and compliance. See everything from traceability to complaint trending, all in one view.