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Description
Arena's quality management system (QMS) software, designed specifically for product-centric environments, empowers medical device manufacturers to efficiently bring safe and compliant products to the market. By integrating quality and product processes, Arena QMS simplifies the new product development and introduction (NPDI) process. It provides assurance of regulatory compliance with essential quality standards and regulations, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS improves visibility and traceability by managing quality processes in conjunction with various essential documentation, including bills of materials (BOMs), standard operating procedures (SOPs), device master records (DMRs), design history files (DHFs), specifications, drawings, and training plans. This holistic approach not only facilitates compliance but also fosters a culture of quality throughout the organization.
Description
Empower your team by enabling them to take control of their processes. With user-friendly, no-code tools for procedure and recipe creation tailored for process scientists and engineers, your team can effortlessly configure Tempo without any coding expertise. Tempo facilitates real-time collaboration, allowing users from your company, as well as partners and customers from CDMO, to co-author recipes using live group-editing features. Users can swiftly design sophisticated workflows that incorporate advanced functionalities such as parallel execution, branching, and enforcement logic, along with the ability to integrate referenceable parameters, formulas, equipment, materials, and operator actions, all without writing any code. Additionally, any user can enhance procedures by incorporating augmented guidance, including photos, videos, and AR overlays, into any procedural step. Our mobile application and voice-activated headset are designed to accompany you wherever you go, ensuring usability in various settings – from suites and cleanrooms to environments where personal protective equipment is worn. This versatility allows teams to maintain productivity and efficiency, regardless of the circumstances.
API Access
Has API
API Access
Has API
Integrations
Rimsys
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Arena, a PTC Business
Founded
2000
Country
United States
Website
www.arenasolutions.com/platform/qms/
Vendor Details
Company Name
Apprentice.io
Founded
2014
Country
United States
Website
www.apprentice.io/product/packages/manufacturing-execution-system
Product Features
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Product Features
Manufacturing Execution
Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability