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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

Quality Planning Studio's FMEA software combines essential quality tools while guaranteeing compliance with key process flow stages. This all-in-one software solution facilitates the planning, documentation, and oversight of vital quality standards. For manufacturers around the globe, FMEA has become a crucial element of ongoing improvement initiatives. The interconnectedness of Process Flows, FMEA, control plans, and SPC is pivotal to fostering quality enhancement. Through the FMEA process, there is a continuous drive to refine products, processes, or detection methods. Engineers engaged in the FMEA process receive ongoing insights from SPC outcomes observed on the shop floor. The QPS database effectively centralizes all information, maintaining the traceability and integrity of your Process Flow, FMEA, and Control Plan data across various manufacturing locations. Additionally, QPS can integrate with our SPC software, DataMetrics, which streamlines operations by minimizing redundancy while enabling effective monitoring of characteristic capabilities derived from the Control Plan. This seamless integration ultimately enhances overall operational efficiency and quality assurance.

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

$2000.00/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

DATAMYTE

Founded

1967

Country

United States

Website

www.datamyte.com/qps

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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