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Jira Data Center

Ketryx transforms both Jira Cloud and Jira Data Center into a validated, IEC 62304-compliant platform for medical device development. Let your developers work in the modern tools they love, while Ketryx enables an IEC 62304-compliant process in the background. Ketryx ensures seamless traceability, automated documentation, SOP enforcement, and risk management, all from within Jira.

Top Capabilities

Transform Jira into a validated, compliant platform for regulated product development with Ketryx.

Traceability across the total product lifecycle

Ketryx ensures seamless traceability, allowing you to track every aspect of your product's lifecycle. From user requirements to specs to tests, while you're working in Jira. Easily view dependencies and relationships between requirements, specifications, tasks, risks, and tests through the traceability widget in Jira.

Keep your developers' work 62304-compliant

Ketryx enforces your SOPs in Jira so your developers' work stays compliant. Gate releases and approvals in a way that aligns with your quality processes. V&V tests won't run for uncontrolled requirements or unapproved test cases. Once approved, items are immutable to prevent process deviation.

Part 11-compliant signatures in Jira

Keep your developers in Jira with Part 11-compliant secure and legally binding electronic signatures. Electronic signatures meet 21 CFR Part 11 requirements, providing a secure, verifiable way to approve documents and changes. Be audit-ready by ensuring all electronic records are authenticated, authorized, and tamper-proof.

Automated document generation

Automatically transform the work you do in Jira into compliant documentation. Every Jira ticket and change is automatically used to create a Part 11-compliant audit trail. Automatically generated documents are structured to meet compliance requirements so that you're audit-ready.

Risk management in Jira

Ketryx integrates IEC 62304 and ISO 14971-compliant risk management features into your Jira platform, enabling proactive identification and mitigation of risks. Track and evaluate risks continuously as they appear and establish traceability, all within Jira.

Keep your tools, and your teams, in sync

Connect Jira, GitHub, Azure DevOps, Polarion, and more. Ketryx bi-directionally syncs key fields and maps work items across tools into a unified schema, enabling cross-team collaboration without disrupting existing workflows.

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