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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 ISO 13485 Quality Management?

IMSXpress is a sophisticated platform tailored for the administration of document control, the assurance of regulatory compliance, and the management of quality systems in accordance with ISO 13485 and FDA 21 CFR part 820 regulations. It includes a range of features such as document distribution, control, CAPA management, complaint resolution, auditing, training oversight, MDR processes, supplier management, and tracking of non-conforming products. This cutting-edge software is available for either local installation or cloud deployment, and it comes with a variety of pre-built template manuals, procedures, employee training resources, and audit checklists to facilitate a smooth implementation process. Furthermore, its user-friendly interface significantly improves the overall experience, making the management of compliance more streamlined and effective than ever before. Consequently, organizations can ensure they remain up-to-date with regulatory demands while enhancing their operational efficiency.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

$17 USD/month/user
Recurring subscription pricing based on number of users and modules
Free Trial Offered?

Pricing Information

$1460.00/one-time
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Windows

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub
Webinars

Company Facts

Organization Name

isoTracker Solutions Ltd

Date Founded

2004

Company Location

United Kingdom

Company Website

www.isotracker.com

Company Facts

Organization Name

AQA

Date Founded

1992

Company Location

United States

Company Website

www.imsxp.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
Risk Management
Training Management

Categories and Features

Compliance

Archiving & Retention
Audit Management
FDA Compliance
ISO Compliance
Version Control

ISO Compliance

Not specified

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