Quality Management Software Questions & Answers

Yes, Arena QMS can generate reports for both audits and regulatory submissions. It centralizes documentation and workflows, enabling easy access to records for audits and facilitating the creation of reports for regulatory compliance.

Arena QMS price details are not available on the official website. However, to know the pricing, you can directly contact with the Arena QMS support through the Contact Us section on the website.

Arena QMS facilitates collaboration among dispersed teams through a cloud-based platform that provides secure access to the latest product information, promotes teamwork through notifications, and enables controlled access to specific data based on user roles.

Arena QMS integrates with product development processes by connecting quality and product records, streamlining workflows, and facilitating collaboration.

Yes, Arena QMS is a customizable platform that can be tailored to meet specific organizational needs.

Here are some tools are available for managing Corrective and Preventive Actions (CAPAs):

Popular CAPA Management Tools

• SimplerQMS
• ProcessNavigation CAPA Software
• Lean Sigma CAPA Guide
• Arena QMS
• ETQ Reliance
• MasterControl CAPA

Arena QMS supports software validation for regulatory compliance by streamlining the process of demonstrating compliance with regulations like ISO 13485 and FDA Title 21 CFR 820.30.

The analytics tools included in Arena QMS for monitoring quality metrics are:

• Preconfigured Dashboards
• Customizable Reports & KPIs
• Root Cause Analysis
• Supplier Quality Monitoring
• Audit & Compliance Tracking
• Real-Time Data Insights

Arena QMS is a product-centric, cloud-native quality management system (QMS) that connects quality and product processes in a single, secure system. It supports product-centric quality management by integrating quality processes with the product record and bill of materials (BOM), providing better visibility and traceability throughout the product lifecycle.

Arena QMS ensures compliance with FDA, ISO, and EU MDR regulations by providing a cloud-based, product-centric quality management system that integrates quality and product records, enabling better control and traceability throughout the product lifecycle.