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Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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

AutoDCP facilitates the linking of individual projects or specific operations into a unified composite project, which proves beneficial for integrating purchased components, various parts, or generic processes alongside part-specific details. This feature ensures that any changes in the foundational data automatically reflect in the composite projects. Furthermore, AutoDCP stands out as the quickest and most economical solution for sustaining an interconnected Process Flow Diagram, FMEA, and Control Plan. The inclusion of Risk Profiles streamlines the FMEA creation process, making it both efficient and rapid. Its user-friendly drag-and-drop interface simplifies the FMEA development experience, allowing users to navigate the system with ease. Additionally, AutoDCP is equipped with numerous features that significantly enhance productivity, demonstrating that the process of creating and updating FMEAs and Control Plans can be accomplished in a fraction of the time it would traditionally require. Ultimately, these advancements help teams focus more on analysis and less on administrative tasks.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Rimsys

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

Customer Driven Systems

Country

United States

Website

www.customerdriven.com

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

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

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