Description
Key Features and Benefits
- Connected QMS & Product Management – Seamlessly integrates quality records with product design, bill of materials (BOM), and engineering changes.
- Regulatory Compliance & Audit Readiness – Ensures adherence to ISO 13485, FDA 21 CFR Part 820, and other industry standards, reducing audit risks.
- Closed-Loop Quality Control – Tracks CAPAs, defects, supplier quality, complaints, and risk management throughout the product lifecycle.
- Scalable, Cloud-Based Platform – Provides anytime, anywhere access with role-based controls for collaboration with suppliers and contract manufacturers.
- Advanced Document & Training Management – Centralized control of standard operating procedures (SOPs), training records, and compliance documents.
- Integrated with Leading Business Systems – Connects with Jira, Dynamics 365, NetSuite, Sage 100, and Onshape for seamless operations.
Key Differentiators
- Product-Centric Approach – Unlike standalone QMS tools, Arena integrates quality processes with engineering and product development.
- Cloud-Based Collaboration – Supports multi-site teams, contract manufacturers, and regulatory auditors with secure, remote access.
- Customizable Workflows & Automation – Reduces manual data entry and speeds up change management and approvals.
- Strong BOM & Supplier Management – Offers full traceability across the supply chain for defect tracking and compliance.
