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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 Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
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 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 Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

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 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 

Product Features

Calibration Management

Calibration Instructions Yes 
Calibration Schedules Yes 
Compliance Management Yes 
Device History Yes 
Due Date Tracking Yes 
Gage Management Yes 
Label Printing No 
Measurement Readings Yes 
Multi-Station Management No 
Out-of-Tolerance Notification Yes 
Statistical Data Reporting No 

CMMS

Asset Tracking Yes 
Calibration Management Yes 
Inventory Control No 
Key & Lock Management No 
Mobile Access No 
Preventive Maintenance Yes 
Purchasing No 
Scheduling Yes 
Service History Tracking Yes 
Technician Management Yes 
Work Order Management Yes 

Equipment Maintenance

Customer Database No 
Dispatch Management No 
Equipment Tracking Yes 
Inventory Control Yes 
Job Management Yes 
Maintenance Scheduling Yes 
Warranty Tracking Yes 
Work Order Management Yes 

Maintenance Management

Asset Tracking Yes 
Billing & Invoicing No 
Calibration Management Yes 
Dispatch Management No 
Inventory Control Yes 
Inventory Management Yes 
Key & Lock Management No 
Mobile Access Yes 
Planning Calendar Yes 
Predictive Maintenance Yes 
Preventive Maintenance Yes 
Purchasing No 
Scheduling Yes 
Service History Tracking Yes 
Technician Management Yes 
Work Order Management Yes 

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