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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
Whether you are providing services or overseeing your own compliance needs, ZetaSafe is here to assist you in fulfilling your compliance requirements, ensuring the safety and security of your personnel and facilities. We are excited to share that Micad has successfully acquired Zeta Compliance Technologies LLC (SEER), the North American distributor of ZetaSafe software. With ZetaSafe, you can effortlessly track and manage your compliance responsibilities with high precision. This solution offers enhanced oversight of data, costs, labor, and operational procedures. Additionally, it features a comprehensive audit trail that provides reassurance that all necessary monitoring is conducted punctually. You will also gain real-time insights into your data, key performance indicators, and emerging trends. The system's automatic escalation of non-compliance issues allows for prompt and effective management of any failures or defects. It covers important regulations such as HSG274, HTMs (including HTM 04:01), the RRO Fire Safety 2005, and SFG20. Take the opportunity to book a demo and discover how ZetaSafe can optimize your processes. With capabilities to scan barcodes, input compliance data, and generate insightful trends and reports, ZetaSafe works alongside you to evaluate your compliance management strategies and tailor the software to meet your specific compliance needs. Collaborating with you ensures that all aspects of your compliance are meticulously managed and maintained.
API Access
Has API
API Access
Has API
Integrations
Rimsys
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$500.00/month
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
ZetaSafe
Website
www.zetasafe.com
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