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
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
No
API Access
Has API
No
Integrations
Rimsys
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
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
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
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)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
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
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
Yes
Complaint Management
Yes
Compliance Management
No
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
Yes