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What is Nova-CPM?

Novatek International provides a wide range of software solutions that not only meet but also exceed the essential quality and compliance standards required in the life sciences industry. Their specialized offerings create a cohesive platform that guarantees consistency and standardization across various departments, whether within a single site or across multiple locations. This seamless integration notably reduces the total cost of ownership while improving the return on investment. One of their standout products, the NOVA-CPM tool, serves as an advanced automation solution that proficiently oversees all facets of equipment qualification, calibration, and maintenance procedures. Built with a focus on global regulatory compliance and safeguarding data integrity, the system is equipped with strong security measures, electronic signatures, and thorough audit trails. As a leading Computerized Maintenance Management System (CMMS), NOVA-CPM manages the entire lifecycle of equipment, catering to requirements from initial purchase and validation through calibration, maintenance tasks, repairs, and, ultimately, end-of-life replacement. This comprehensive methodology ensures that organizations can uphold operational efficiency while simultaneously complying with rigorous regulatory standards. Moreover, Novatek's commitment to innovation in software development reinforces their position as a trusted partner in the life sciences sector.

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

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

www.ntint.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 Schedules
Compliance Management
Device History
Due Date Tracking
Label Printing
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

Life Sciences

Not specified

Categories and Features

Calibration Management

Calibration Instructions
Calibration Schedules
Due Date Tracking

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Training Management

Change Management

Approval Workflow
Audit Trail
Release Management
Task Management
Training Management

Complaint Management

Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Issue Tracking
Quality Assurance Management
Routing

Document Version Control

Access Controls/Permissions
Approval Process Control
Audit Trail
Revision History

Equipment Management

Not specified

Preventive Maintenance

Maintenance Scheduling
Reminders

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Vendor Management

Audit Management
Vendor Qualification Tracking

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