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What is Nova-QMS?

Maintaining consistent product quality and effective quality management systems presents considerable obstacles in today's pharmaceutical manufacturing environment. Sectors subject to rigorous regulations, such as Pharmaceuticals, Biotechnology, and Life Sciences, are required to follow Good Manufacturing Practices (GMP) to meet legal requirements. However, simply meeting GMP standards is not sufficient; organizations must also demonstrate compliance through proper documentation. Utilizing paper-based forms, disconnected systems, or manual processes to manage, track, and document quality-related issues and their resolutions does not provide adequate solutions for creating cohesive and integrated quality management systems that meet industry expectations. As a result, it becomes imperative for organizations to adopt more sophisticated and automated solutions to bolster their quality assurance initiatives and facilitate smoother compliance processes, ultimately leading to improved operational efficiency and product safety.

What is AssurX?

The AssurX platform serves as an advanced software solution for enterprise quality management (EQMS) and regulatory compliance, enabling effective communication and coordination of information, documentation, and activities. By utilizing AssurX, regulated organizations can swiftly pinpoint and manage quality concerns and risk factors, thereby preventing issues related to quality or compliance while also enhancing workflow efficiency. The QMS software from AssurX is specifically designed to be customizable, accommodating both stable and evolving business needs. It establishes a digital workflow encompassing tasks, alerts, escalations, and approvals, which can be automated according to specific requirements, accurately reflecting real-world processes. There is no other system that matches its ease of deployment, configuration, and adaptability, making it a standout choice for businesses. In addition, AssurX solutions work together seamlessly to form an interconnected quality management system. These offerings include features such as audit management, corrective actions, training management, complaint management, document management, change control, risk management, and EHS incident management, among others, ensuring comprehensive coverage of quality management needs. Ultimately, the integration of these solutions supports organizations in achieving higher standards of quality and compliance across their operations.

Media

Media

Integrations Supported

Integrations Supported

Agile CRM
Blue Link ERP
Expandable
JD Edwards EnterpriseOne
Microsoft 365
Microsoft Access
Microsoft Azure
Microsoft Dynamics 365
NetSuite
Oracle BPM Suite
Oracle Business Intelligence (OBIEE)
Oracle CRM On Demand
Oracle Cloud Infrastructure
Oracle PeopleSoft
QAD Adaptive ERP
QUMAS EQMS
SAP Analytics Cloud
SAP Business One
SAP BusinessObjects Business Intelligence
Salesforce

API Availability

API Availability

Has API

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Windows
Mac

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

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

ntint.com/product/nova-qms/

Company Facts

Organization Name

AssurX

Date Founded

1993

Company Location

United States

Company Website

www.assurx.com

Categories and Features

Life Sciences

Not specified

Quality Management

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

Categories and Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

Complaint Management

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

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Surveys & Feedback
Version Control
Workflow / Process Automation

Energy Management

Compliance Management
Risk Management

Life Sciences

Not specified

Manufacturing

Quality Management
Safety Management

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

Regulatory Reporting

Not specified

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