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Ratings and Reviews 16 Ratings

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Ratings and Reviews 1 Rating

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features
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support

What is isoTracker Quality Management?

isoTracker Quality Management is a widely recognized cloud-based quality management software (QMS) that serves organizations globally in overseeing their compliance with various ISO standards such as ISO 9001, ISO 13485, ISO 22000, ISO 17025, and ISO 14001, among others. This versatile solution is designed as a modular platform, allowing businesses to tailor it according to their unique needs while maintaining a competitive pricing structure and providing exceptional customer support. Organizations can choose from a variety of modules, including Document Control, Complaints, CAPA, Audits, Training, Non-Conformance, and Risk, to create a customized quality management system that addresses all aspects of their operations effectively. By utilizing isoTracker, companies can enhance their quality management processes and ensure ongoing compliance with industry standards.

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.

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

$13.96 USD/month/user
Free Trial Offered?
Free Version

Pricing Information

$799 per month
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

isoTracker Solutions Ltd

Date Founded

2004

Company Location

United Kingdom

Company Website

www.isotracker.com

Company Facts

Organization Name

Qualcy Systems

Date Founded

2014

Company Location

United States

Company Website

www.qualcy.com

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

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

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

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