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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 FactoryTalk PharmaSuite?

FactoryTalk® PharmaSuite is recognized as the leading MES solution specifically designed for the Life Sciences industry. It significantly improves every stage of the recipe life cycle through targeted optimization tailored to individual roles, resulting in faster outcomes for all parties involved. The system features an open-content architecture along with a sophisticated upgrade process, facilitating substantial growth in both batch and discrete manufacturing environments. Furthermore, FactoryTalk PharmaSuite MES provides value-driven applications that help organizations navigate the complexities of regulatory compliance. By implementing this MES, businesses can boost operational efficiency, enhance supply chain management, and make strides towards their sustainability goals. In addition to overseeing production operations, PharmaSuite MES strengthens compliance with regulatory standards while enhancing overall operational performance and supply chain efficiency. With its commitment to fostering production effectiveness, speeding up time-to-market, and simplifying compliance, this contemporary MES solution becomes essential for innovative companies. Ultimately, adopting PharmaSuite equips organizations with a vital advantage in a rapidly changing industry landscape, positioning them for future success. As the industry evolves, leveraging such advanced solutions becomes increasingly important for maintaining competitiveness.

Media

Media

Integrations Supported

FactoryTalk

Integrations Supported

FactoryTalk

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

Rockwell Automation

Date Founded

1903

Company Location

United States

Company Website

www.rockwellautomation.com/en-us/products/software/factorytalk/operationsuite/mes/life-sciences.html

Categories and Features

Manufacturing

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

Categories and Features

Manufacturing Execution

Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability

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