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Average Ratings 0 Ratings

Total
ease
features
design
support

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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

ThinkTeam PDM has the capability to systematically arrange documents and components, effectively handling various bill of materials irrespective of their format and originating source. By implementing structured rules, it streamlines storage methods and triggers the original applications for file modifications or to present necessary applications. This solution promotes interdepartmental collaboration, fostering both innovation and product standardization. It significantly minimizes low-value tasks such as information gathering, data entry, manual creation of bills of materials, obtaining signatures and approvals, and printing, among others. Additionally, enhancing product quality is achieved by diminishing errors throughout the entire product development cycle and ensuring accurate documentation generation. Ultimately, this leads to a more efficient workflow and improved overall productivity in an organization.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

NCG CAM
Rimsys

Integrations

NCG CAM
Rimsys

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$4900.00/one-time/user
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

DPTLab

Country

Italy

Website

www.dptcorporate.com/products/

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

Product Data Management

Bill of Material Management
Document Management
Formula Management
Product Analytics
Product Lifecycle Management
Testing Management
Version Control

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