Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
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