Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Monitoring performance and documenting results is crucial for operational efficiency. Reach out to us to access a demo account or to establish your organization within our system. You can easily download the 80/20 Quality app from the Apple App Store, Google Play, or access it through our web platform. Tailor the dropdown menus according to your specific requirements. Inspectors on the production floor can utilize the 80/20 Quality App to record non-conformances, providing comprehensive details and images to effectively communicate the issues to key decision-makers in your organization. Upon detection of an issue, management is promptly notified, allowing them to determine the necessary actions for manufacturing, whether that involves fixing, scrapping, or returning the non-conformance. The inspector is subsequently notified via the app with clear guidance on the next steps to take. After completing the approved actions, the inspector documents the resolution, ensuring each task is recorded. Additionally, all activities are tracked for data collection and analysis, enabling the identification of trends and potential areas for improvement, ultimately fostering a culture of continuous enhancement within the organization.
Description
A web-based software suite for medical device companies that automates their processes and simplifies regulatory compliance. Modules include Audit Management, CAPA and Complaint Handling. Designed from the start for ISO 13485 compliance and 21 CFR Part 11 compliance.
API Access
Has API
No
API Access
Has API
Yes
Integrations
No details available.
Integrations
No details available.
Pricing Details
$900/year
$900/year for up to 5 users
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
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
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
CFA Solutions
Founded
2017
Country
United States
Website
www.8020quality.com
Vendor Details
Company Name
Grand Avenue Software
Founded
2002
Country
United States
Website
www.grandavenue.com
Product Features
Quality Management
Audit Management
No
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
Yes
Document Control
No
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
No
Supplier Quality Control
Yes
Training Management
No
Product Features
Calibration Management
Calibration Instructions
Yes
Calibration Schedules
Yes
Compliance Management
No
Device History
No
Due Date Tracking
Yes
Gage Management
No
Label Printing
No
Measurement Readings
No
Multi-Station Management
No
Out-of-Tolerance Notification
No
Statistical Data Reporting
No
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
No
Root Cause Analysis
No
Training Management
Yes
Change Management
Approval Workflow
Yes
Audit Trail
Yes
Automated Notifications
No
Change Calendar
No
Change Planning
No
Compliance Management
No
Prioritization
No
Release Management
Yes
Task Management
Yes
Tracking & Reporting
No
Training Management
Yes
Complaint Management
Case Management
No
Complaint Classification
Yes
Corrective Actions (CAPA)
Yes
Customer Complaint Tracking
Yes
Feedback Management
No
Forms Management
No
Issue Tracking
Yes
Quality Assurance Management
Yes
Routing
Yes
Self Service Portal
No
Social Media Monitoring
No
Survey Management
No
Document Version Control
Access Controls/Permissions
Yes
Approval Process Control
Yes
Archiving & Retention
No
Audit Trail
Yes
Commenting / Notes
No
Document Check-in / Check-out
No
For Engineering Documents
No
Revision History
Yes
Version Comparison
No
Version Rollback
No
Preventive Maintenance
Condition Monitoring
No
Inspection Management
No
Maintenance Scheduling
Yes
Mobile Access
No
Predictive Maintenance
No
Purchasing
No
Reminders
Yes
To-Do List
No
Vendor Management
No
Work Order Management
No
Quality Management
Audit Management
Yes
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
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Vendor Management
Audit Management
Yes
Contact Management
No
Customer Database
No
Self Service Portal
No
Supplier Master Data
No
Transaction History
No
Vendor Maintained Profiles
No
Vendor Managed Inventory
No
Vendor Performance Rating
No
Vendor Qualification Tracking
Yes