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
ThinkTeam PDM has the capability to systematically arrange documents and components, effectively handling various bill of materials irrespective of their format and originating source. By implementing structured rules, it streamlines storage methods and triggers the original applications for file modifications or to present necessary applications. This solution promotes interdepartmental collaboration, fostering both innovation and product standardization. It significantly minimizes low-value tasks such as information gathering, data entry, manual creation of bills of materials, obtaining signatures and approvals, and printing, among others. Additionally, enhancing product quality is achieved by diminishing errors throughout the entire product development cycle and ensuring accurate documentation generation. Ultimately, this leads to a more efficient workflow and improved overall productivity in an organization.
API Access
Has API
No
API Access
Has API
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
$4900.00/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
No
Live Rep (24/7)
Yes
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
DPTLab
Country
Italy
Website
www.dptcorporate.com/products/
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
Product Data Management
Bill of Material Management
No
Document Management
No
Formula Management
No
Product Analytics
No
Product Lifecycle Management
No
Testing Management
No
Version Control
No