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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.
Description
Unwind and discover how GxPReady! Suite can assist you in fulfilling your obligations without stretching your budget, featuring Calibration, Validation, and Maintenance modules that can function both collaboratively and independently to provide you with exceptional adaptability. Getting started is a breeze, requiring little disruption to your IT infrastructure. With secure web access, you can achieve validation efficiently while maintaining your existing processes with minimal data entry required. Our suite of validated SaaS solutions is specifically crafted to support managers of FDA-regulated organizations in adhering to regulatory standards, such as cGMPs, 21CFR11, and Annex 11 requirements. Additionally, our validated CMMS system is available on a subscription basis, allowing you to launch your equipment management system with low initial costs. Furthermore, our innovative Flash Validation method for qualification ensures the quickest path to GxP compliance possible. Experience the ease and efficiency of our solutions today!
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
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
Grand Avenue Software
Founded
2002
Country
United States
Website
www.grandavenue.com
Vendor Details
Company Name
GxPReady.com
Founded
2011
Country
United States
Website
gxpready.com
Product Features
Calibration Management
Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Change Management
Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management
Complaint Management
Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management
Document Version Control
Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback
Preventive Maintenance
Condition Monitoring
Inspection Management
Maintenance Scheduling
Mobile Access
Predictive Maintenance
Purchasing
Reminders
To-Do List
Vendor Management
Work Order Management
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
Vendor Management
Audit Management
Contact Management
Customer Database
Self Service Portal
Supplier Master Data
Transaction History
Vendor Maintained Profiles
Vendor Managed Inventory
Vendor Performance Rating
Vendor Qualification Tracking
Product Features
Calibration Management
Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting
CMMS
Asset Tracking
Calibration Management
Inventory Control
Key & Lock Management
Mobile Access
Preventive Maintenance
Purchasing
Scheduling
Service History Tracking
Technician Management
Work Order Management
Equipment Maintenance
Customer Database
Dispatch Management
Equipment Tracking
Inventory Control
Job Management
Maintenance Scheduling
Warranty Tracking
Work Order Management
Maintenance Management
Asset Tracking
Billing & Invoicing
Calibration Management
Dispatch Management
Inventory Control
Inventory Management
Key & Lock Management
Mobile Access
Planning Calendar
Predictive Maintenance
Preventive Maintenance
Purchasing
Scheduling
Service History Tracking
Technician Management
Work Order Management