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What is Qualcy QMS?

Qualcy Biomed's quality management system (QMS) software is tailored specifically for biomedical enterprises, such as those in biotechnology and pharmaceuticals, to effectively handle QMS documentation in line with FDA and ISO 13485 standards. It ensures adherence to 21 CFR Part 820 and incorporates essential features like electronic signatures, audit trails, and compliance with 21 CFR Part 11. Additionally, the software facilitates the management of document change control, complaint handling, audits, corrective and preventive actions (CAPA), non-conformance records, and training records, among other critical functions, ensuring a comprehensive solution for quality management. This robust platform ultimately supports organizations in maintaining high standards of compliance and operational efficiency in their quality processes.

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!

Media

Media

Integrations Supported

AWS Backup
AWS Cloud9
Gmail
Microsoft 365
Microsoft Azure
Microsoft Outlook
SAP Analytics Cloud

Integrations Supported

AWS Backup
AWS Cloud9
Gmail
Microsoft 365
Microsoft Azure
Microsoft Outlook
SAP Analytics Cloud

API Availability

Has API

API Availability

Has API

Pricing Information

$799 per month
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

Qualcy Systems

Date Founded

2014

Company Location

United States

Company Website

www.qualcy.com

Company Facts

Organization Name

GxPReady.com

Date Founded

2011

Company Location

United States

Company Website

gxpready.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

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

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

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