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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.

What is Impurity Profiling Suite?

In order to comply with ICH M7 regulations, it is essential to forecast genotoxic and carcinogenic outcomes for impurities and degradation products. The Impurity Profiling Suite serves as a valuable resource in your ICH M7 process, assisting you in the preparation of regulatory documents while ensuring adherence to compliance standards. This tool not only streamlines your workflow but also enhances the accuracy of your assessments.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Windows
Mac

Supported Platforms

Windows

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Not specified

Company Facts

Organization Name

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

www.ntint.com

Company Facts

Organization Name

ACD/Labs

Date Founded

1994

Company Location

Canada

Company Website

www.acdlabs.com/products/percepta-platform/impurity-profiling-suite/

Categories and Features

Manufacturing

Quality Management
Reporting/Analytics

Categories and Features

Drug Discovery

Not specified

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