Description
Key Features and Benefits
- End-to-End Compliance – Supports ISO 14971, ISO 13485, and IEC 62304 standards.
- QMS and ALM Integration – Manages document control, risk management, CAPA, ECO, supplier quality, and training within one system.
- Automated Quality & Risk Management – Enables traceability between requirements, risks, test cases, and defects for full compliance.
- Audit and Regulatory Readiness – Tracks nonconformances, complaints, and regulatory documentation to ensure audit success.
- Electronic Document Control – Provides revision tracking, approval workflows, and e-signatures to maintain compliance.
- ALM/PLM Features – Supports requirements management, test case execution, and defect tracking.
- Supplier Management & Calibration – Manages vendor qualifications, supplier ratings, and equipment calibration records.
- Collaboration & Reporting Tools – Custom dashboards, real-time analytics, and team collaboration features.
Key Differentiators
- Integrated ALM + QMS – Provides a unified solution for product development and compliance.
- Highly Configurable – Supports custom workflows, role-based permissions, and automated processes.
- Cloud-Based & Scalable – Access the system from anywhere with web-based deployment.
- Third-Party Integrations – Works with Salesforce, Jira, Microsoft Teams, and Office 365.
