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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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Rimsys Yes 

Integrations

Rimsys No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$2000.00/one-time/user
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based No 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

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 Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Product Features

Quality Management

Audit Management No 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

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