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What is GxPReady! Suite?

Relax and explore how the GxPReady! Suite can help you meet your regulatory responsibilities without exceeding your financial limits, equipped with Calibration, Validation, and Maintenance modules that can work together or separately to offer remarkable flexibility. Initiating the process is simple, causing minimal disruption to your current IT setup. With secure web access, you can efficiently achieve validation while preserving your existing workflows and keeping data entry to a minimum. Our suite of validated SaaS solutions is expertly designed to assist managers within FDA-regulated organizations in meeting compliance requirements such as cGMPs, 21CFR11, and Annex 11. Additionally, our validated CMMS system is offered on a subscription model, enabling you to implement your equipment management system at a low initial investment. Moreover, our cutting-edge Flash Validation technique for qualification promises the fastest route to GxP compliance available. Embrace the simplicity and effectiveness of our solutions today, and transform your compliance journey into a streamlined experience!

What is Grand Avenue Software?

An online software solution tailored for medical device manufacturers that streamlines their operations and eases adherence to regulatory standards. This suite features modules such as Audit Management, Corrective and Preventive Actions (CAPA), and Complaint Handling. It has been specifically developed to ensure compliance with ISO 13485 and 21 CFR Part 11 from the outset, providing a robust framework for quality management. Additionally, its user-friendly interface allows companies to efficiently navigate complex compliance requirements while maintaining high standards of product safety and effectiveness.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

GxPReady.com

Date Founded

2011

Company Location

United States

Company Website

gxpready.com

Company Facts

Organization Name

Grand Avenue Software

Date Founded

2002

Company Location

United States

Company Website

www.grandavenue.com

Categories and 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

Categories and 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

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