# Transform Jira into IEC 62304 compliance

Make Jira, the most widely used project management platform for software development worldwide, work for you.

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## Jira was not designed for regulated development. Teams using Jira face issues with:

- Maintaining immutable records and electronic signatures  
- Enforcing control over Total Product Life Cycle (TPLC)  
- Validating the Non-Product Software (NPS) toolchain  
- Tracing across other systems  
- Visibility into validated Software Development Lifecycle (SDLC)

### Transform Jira into a validated, compliant platform for medical device development

Ketryx transforms Jira into a compliant platform for medical device development, no bespoke customizations or expensive consultants needed.

[Watch recorded webinar](/content/learn/webinars/register/making-jira-fit-for-62304-developing-fda-compliant-software/index.html)

## Let your developers work in the modern tools they love, while Ketryx enables an IEC 62304-compliant process in the background.

### 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.

- Track every change with end-to-end traceability across the entire product lifecycle, from initial design to final release.  
- Easily view dependencies and relationships between requirements, specifications, tasks, risks, and tests through the traceability widget in Jira.

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### 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, i.e., V&V tests won’t run for uncontrolled requirements or unapproved test cases.  
- Prevent unauthorized or untrained personnel from approving.  
- 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 within Jira.

- 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.

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### Automated document generation

Automatically transform the work you do in Jira into compliant documentation. Ketryx automates evidence collection and documentation creation directly from Jira, eliminating tedious manual documentation.

- Every Jira ticket and change is automatically used to create a Part 11-compliant audit trail.  
- Automatically generated documents are structured to meet IEC 62304 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 in Jira.  
- Identify and manage risks in Jira throughout the development process with risk mitigation integrated into every stage.

## Accelerate development across your AI lifecycle with Ketryx.