Description
Key Features and Benefits
- Comprehensive QMS & PLM Integration – Unites quality, engineering, and product management into one platform.
- Regulatory Compliance – Supports FDA 21 CFR Part 820, Part 11, ISO 13485, ISO 9001, and EU MDR.
- Supplier & Audit Management – Tracks supplier qualification, rating, onboarding, and collaboration.
- Automated FDA Submissions – Includes electronic AS2 submissions for regulatory compliance.
- Change & Document Control – Offers revision tracking, redlines for documents, and approval workflows.
- CAPA, SCAR, and NCR Management – Facilitates corrective and preventive actions, supplier corrective actions, and nonconformance reports.
- Training & Compliance Tracking – Manages training records, certifications, and audit readiness.
- BOM Management & Product Design Control – Provides full traceability of product components and design changes.
- Seamless Integration with Salesforce – Ensures real-time monitoring, analytics, and business intelligence reporting.
Key Differentiators
- Salesforce-Based Infrastructure – Provides scalability, security, and CRM integration.
- Real-Time Data & Reporting – Offers dashboarding tools for compliance monitoring and operational insights.
- Cloud-Native & Highly Configurable – Allows custom workflows, automated approvals, and personalized user experiences.
- Supplier Collaboration & Secure Access – Includes a Supplier Community Portal for easy engagement.
