Ketryx

Softver za upravljanje usklađenošću

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Ketryx offers a thorough Connected Lifecycle Management platform designed specifically for regulated medical applications, ensuring compliance with FDA, EU MDR, and ISO standards.

The software streamlines the development process for medical devices, integrating seamlessly with popular DevTools to improve traceability, automate documentation, and enforce quality management systems throughout the software development lifecycle.

Ketryx se može naći u Compliance Management Software kategorije.

Najsličniji proizvodi za Ketryx su:

Cascade Potvrđeni profil Promovirano → Greenlight Guru → Threeqa Potvrđeni profil → Aligned Elements → Unifize →

Snimke zaslona

Detalji

Glavne značajke Ketryx

• eQMS
  Ketryx provides an electronic quality management system that works well with other tools.
• QA/RA Support
  It ensures your quality management system is followed and keeps your software ready for audits.
• GxP Validation
  It simplifies the process of validating software that meets Good Practice guidelines.
• Component Reuse
  Ketryx allows you to reuse parts of your software to speed up development.
• Risk Management
  It helps you control and document risks in a way that meets international standards.
• SBOM Visibility
  You can see a complete view of your open-source software supply chain from your source code.
• Jira Integration
  It turns Jira into a platform that meets medical device development standards.
• SaMD Development
  Ketryx makes it easier and cheaper to create Software as a Medical Device applications.
• Developer Support
  Ketryx allows developers to use their preferred tools while ensuring compliance and traceability.
• DevTools Integration
  Ketryx connects with your favorite development tools to create traceability and documentation automatically.
• Real-Time Traceability
  Automatically create a traceability matrix that connects items, risks, code, and tests in real-time.
• Automated Documentation
  Ketryx compiles all necessary documents into a ready-to-submit design history file.
• Requirements Management
  Manage and trace requirements across different systems like Jira.
• AI/ML Software Development
  It helps speed up the development and launch of AI and machine learning software while keeping everything compliant.
• Automated Test Traceability
  You can automatically link tests in Git to requirements in Jira.
• Connected Lifecycle Management
  Ketryx is a platform that helps manage the entire life of medical applications in a connected way.
• Quality Management System Enforcement
  It ensures your team follows the defined standard operating procedures.

Ketryx Prednosti

• Reuse Components
  Ketryx allows teams to reuse parts of their software, speeding up development and reducing work.
• Ease GxP Validation
  It simplifies the process of validating software for Good Practice (GxP), saving time and reducing complexity.
• Integrate with DevTools
  Ketryx connects with popular development tools, making it easier to manage projects and stay compliant.
• Simplify SaMD Development
  It makes building Software as a Medical Device easier and faster, saving time and effort.
• Automate Test Traceability
  It automatically links tests in Git to requirements in Jira, helping teams keep track of everything.
• Create Traceability Matrix
  Ketryx automatically builds a traceability matrix, connecting all parts of the project for better oversight.
• Control Risks Automatically
  Ketryx helps identify and document risks in a way that meets safety standards, keeping projects safe.
• Ensure Audit-Ready Software
  Ketryx keeps software ready for audits all the time, preventing issues during inspections.
• Accelerate AI/ML Development
  Ketryx helps speed up the development of AI software while making sure it meets rules and regulations.
• Navigate Compliance with eQMS
  It offers a system that works well with other tools, making it easier to follow compliance rules.
• Support Developer Preferences
  It allows developers to use their favorite tools while still meeting compliance needs.
• Transform Jira for Compliance
  Ketryx turns Jira into a tool that meets medical device rules, making it easier to manage projects.
• View Open-Source Supply Chain
  It provides a clear view of the open-source components used in the software, helping manage risks.
• Manage Requirements Effectively
  It helps teams track and manage requirements across different systems, ensuring nothing is missed.
• Enforce Quality Management System
  Ketryx ensures that teams follow their quality processes, helping maintain high standards.
• Compile Documentation Automatically
  It gathers all necessary documents into a ready-to-submit design history file, making compliance easier.

Tko bi trebao koristiti Ketryx?

• Developers
  They can keep using their favorite tools while Ketryx makes sure everything is compliant and traceable.
• R&D Leaders
  They can focus on building software while Ketryx helps manage changes and documentation easily.
• Project Managers
  They can oversee projects more effectively with real-time traceability and automated documentation.
• Quality Professionals
  They can ensure quality at every stage of the product lifecycle and stay compliant with regulations.
• Regulatory Affairs Teams
  They can streamline the compliance process and reduce the time spent on documentation and validation.

Značke

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