Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
No
API Access
Has API
No
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
Yes
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
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
No
ERP
No
MES
No
MRP
No
Maintenance Management
No
Purchase Order Management
No
Quality Management
Yes
Quotes/Estimates
No
Reporting/Analytics
Yes
Safety Management
No
Shipping Management
No
Product Features
Manufacturing Execution
Document Management
Yes
Forecasting
No
Quality Control
Yes
Quote Management
No
Resource Management
Yes
Supplier Management
Yes
Supply Chain Management
Yes
Traceability
Yes