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Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

Novatek International delivers extensive software solutions that not only fulfill but surpass the quality and compliance standards essential for the life sciences sector. Their process-specific offerings create an integrated platform that ensures uniformity and standardization across various departments within a single site and among multiple locations. This integration significantly lowers the total cost of ownership and enhances the return on investment. The NOVA-CPM tool is a cutting-edge automation solution that expertly manages all aspects of equipment qualification, calibration, and maintenance procedures. Designed with global regulatory compliance and data integrity in mind, the system features robust security protocols, electronic signatures, and comprehensive audit trails. As a premier Computerized Maintenance Management System (CMMS), NOVA-CPM encompasses the entire life cycle of equipment, addressing needs from initial purchase and validation to calibration, maintenance tasks, repairs, and ultimately, end-of-life replacement. This holistic approach ensures that organizations can maintain operational efficiency while adhering to stringent regulatory demands.

Description

Tricentis Vera redefines Digital Validation by going beyond merely affixing electronic signatures to digital documents, instead revolutionizing the Computer Systems Validation process to eliminate cumbersome and unnecessary documentation practices while ensuring compliance is inherently linked to robust software quality measures. By integrating triggers and controls for capturing electronic signatures that comply with 21 CFR Part 11 into Agile software testing workflows, organizations can significantly hasten their time to market with Tricentis Vera. Additionally, Vera offers a unified interface across various tools, serving as a comprehensive system of record that allows users and teams to monitor their review and approval processes in real-time. After validation assets are either submitted for approval or receive the necessary endorsements, the records are securely locked in both qTest and Jira, preventing any alterations during or after the approval phase. This seamless integration ultimately enhances collaboration and streamlines workflows, ensuring that quality and compliance are maintained throughout the software development lifecycle.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Jira
Tricentis Tosca
qTest

Integrations

Jira
Tricentis Tosca
qTest

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Novatek International

Founded

1996

Country

Canada

Website

www.ntint.com

Vendor Details

Company Name

Tricentis

Founded

2007

Country

United States

Website

www.tricentis.com/products/digital-validation-vera/

Product 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

Preventive Maintenance

Condition Monitoring
Inspection Management
Maintenance Scheduling
Mobile Access
Predictive Maintenance
Purchasing
Reminders
To-Do List
Vendor Management
Work Order Management

Product Features

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

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