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Use modern dev tools like Jira when you choose Ketryx over Jama

Comprehensive traceability automatically created throughout all stages of the development process and across any and all systems
  • 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
Integrations
Validated Application Lifecycle

Automated and traceable

Regulated software lifecycle management

Ketryx automatically generates TPLC traceability across all systems and workflows without any duplicative work and prevents product launches without complete compliance with your SOPs.

Create FDA-grade Software

  • Start developing in minutes
  • Use pre-built GxP Development Infrastructure
  • Remove non-value add documentation work

Software Development and Traceability

  • End-to-end traceability using your favorite tools
  • Continues traceability compliance visibility
  • Remove non-value add testing

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

Continuous Configuration Management

  • Assure regulated products are configured, safe, and reliable.
  • Detailed audit-ready configuration
  • Streamline product testing and release
Validated Application Lifecycle

‍How can Ketryx help?

Develop with confidence, maintain control, and prepare your team with the most efficient tools available
Capabilities

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.