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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

In the realm of life sciences manufacturing, prioritizing quality is essential for success. An efficient quality assurance process that enables swift business decisions, maintains regulatory compliance, and guarantees top-notch product quality necessitates a strong system. Assure-IQ is specifically built to meet these demands. When paired with Caliber's Document Management and Training and Learning Management systems, companies can experience an unparalleled quality management journey with Assure-IQ. This solution is crafted to optimize the entire quality assurance framework. With over 30 customizable modules available, you can tailor a platform that meets your specific needs. Additionally, quality processes, document management, and training management can be seamlessly integrated to oversee the entire product lifecycle. The solutions offered, whether on-cloud or on-premise, are developed using cutting-edge technology to adapt to the evolving requirements of the industry. A versatile Quality Management System (QMS) that integrates smoothly with your organization’s existing systems empowers you to establish your own standards for quality excellence. Embracing such a robust system can significantly enhance your operational efficiency and product reliability.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

EPIQ QMS by Caliber
Rimsys

Integrations

EPIQ QMS by Caliber
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

Caliber Technologies

Founded

2001

Country

India

Website

caliberuniversal.com/solutions/quality-management-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

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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