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What is Nova-Stability?

Managing a stability study comes with numerous challenges, which can often result in mistakes. Using a conventional paper-based method increases the likelihood of these inaccuracies. To reduce such risks, it's crucial to implement a software-based system that simplifies the processes of stability studies and evaluations of shelf life. Given the rigorous scrutiny that stability studies undergo from regulatory authorities, it is imperative for organizations to validate the reliability of their results. Automated systems not only boost productivity but also provide critical documentation in real-time, effectively meeting auditors' requirements. Solutions like Nova-Stability enable companies to maintain compliance with regulatory standards while reducing risks related to consumer safety. Nova-Stability is a sophisticated, feature-laden platform that manages the entire workflow of stability testing. This comprehensive tool complies with the latest global regulatory standards. In addition, Nova-Stability's adaptability allows it to cater to various kinds of stability studies, ensuring thorough oversight across a wide range of projects. By employing such advanced solutions, organizations can enhance the overall quality and accuracy of their stability assessments.

What is Nova-Cleaning Validation?

Nova-Cleaning Validation software is essential for enhancing product integrity by adeptly handling changes and assessing the risks related to cross-contamination and impurities in a dynamic production environment. It diligently examines every modification concerning methods, APIs, products, equipment, and family groups to maintain product integrity while ensuring compliance with regulatory requirements. In addition, Nova-Cleaning Validation complies with the stipulations outlined in 21 CFR Part 11 and EU Annex 11, which further solidifies its reliability. The system utilizes a risk-based approach and is thoroughly designed in accordance with PDA Technical Reports 29 and 49, ISPE MaPP, and 21 CFR Part 211.67, positioning it as a trusted option for quality assurance in the pharmaceutical sector. This all-encompassing strategy not only protects product quality but also boosts the overall efficiency of the manufacturing process, ultimately leading to more reliable outcomes for stakeholders. By continuously adapting to new challenges in the industry, it ensures that the highest standards of quality are consistently met.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
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

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

www.ntint.com

Company Facts

Organization Name

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

www.ntint.com

Categories and Features

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

Manufacturing

Accounting Integration
ERP
MES
MRP
Maintenance Management
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management

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