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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

Nova-Cleaning Validation software plays a crucial role in bolstering product integrity by effectively managing modifications and evaluating the risks linked to cross-contamination and product impurities in an ever-changing production landscape. It systematically reviews all alterations related to methods, APIs, products, equipment, and family groups to uphold product integrity and ensure adherence to regulatory standards. Furthermore, Nova-Cleaning Validation adheres to the guidelines set forth in 21 CFR Part 11 and EU Annex 11. The system employs a risk-based strategy and is meticulously crafted in accordance with PDA Technical Reports 29 and 49, ISPE MaPP, and 21 CFR Part 211.67, making it a reliable choice for quality assurance in pharmaceutical manufacturing. This comprehensive approach not only safeguards product quality but also enhances the overall efficiency of the production process.

Description

In today's landscape, businesses must adopt advanced manufacturing IT to enhance their production efficiency. Felten's PILOT:MES, a Manufacturing Execution System (MES), seamlessly combines optimization, quality, and energy management within a cutting-edge platform, enabling production to achieve unparalleled flexibility while ensuring that business processes are fully integrated. The pharmaceutical sector, in particular, faces mounting competitive and profit pressures, exacerbated by ongoing reforms in the healthcare system, which necessitate a concentrated effort to reduce costs in production. In Germany, over seventy-five percent of consumers prioritize a polished appearance, highlighting the importance of quality in the market. However, this emphasis on aesthetics coincides with intense competition that demands rapid adaptation and a steady stream of innovative product ideas. As a result, the production industry is compelled to maintain a high level of flexibility while also streamlining processes to be more cost-effective, which is essential for sustained success. Ultimately, the ability to balance these demands will be crucial for companies aiming to thrive in such a dynamic environment.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

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

FELTEN

Founded

1990

Country

Germany

Website

www.felten-group.com/en

Product Features

Manufacturing

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

Product Features

Manufacturing Execution

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

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