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Average Ratings 0 Ratings

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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

Providing Quality Management Software is essential for managing compliance with various ISO standards, including ISO 9001, ISO 13485, ISO 17025, FDA, GMP, and BRC. This EQMS software is being utilized across a wide range of industries, each with distinct ISO requirements, all with the unified objective of enhancing product quality and maintaining superior standards. While some EQMS applications cater more effectively to large enterprises, others are tailored for small to medium-sized businesses, yet all share critical features that define the best quality management solutions available. Companies can integrate processes like CAPA (Corrective Action Preventative Action) within their EQMS software, and it's important to note that the implementation of these processes may vary significantly between organizations, even within the same industry. The flexibility to customize workflows, forms, and layouts based on the unique operations of a business is crucial for ensuring a seamless adoption of the system. Ultimately, this adaptability not only facilitates compliance but also fosters a culture of continual improvement across all levels of the organization.

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

Sercle

Country

United States

Website

www.serclesoftware.com/quality-management-software/

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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