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
Vimachem’s Pharma 4.0 MES platform stands out as a versatile and entirely modular manufacturing execution system, leveraging the principles of AI and IIoT to facilitate digital transformation in the pharmaceutical and biopharmaceutical sectors. Tailored for environments adhering to cGMP regulations and 21 CFR Part 11 standards, this system provides instantaneous, contextually relevant feedback on the production floor, effectively linking devices, machinery, and personnel to streamline operations from the initial planning stages to the final product delivery, all while upholding strict quality requirements. The platform ensures that information circulates effortlessly throughout the organization, supplying the appropriate data to the relevant teams precisely when needed. By utilizing AI-generated insights, it enhances production efficiency and overall equipment effectiveness (OEE) from the outset, while secure integrations consolidate all plant data into user-friendly dashboards. With the elimination of paperwork, the prevention of compliance issues, and the facilitation of scalable automation, Vimachem enables life-science manufacturers to minimize manual labor, elevate operational performance, and expedite the introduction of essential therapies to the market. Ultimately, this innovative solution not only propels efficiency but also supports the evolving needs of the pharmaceutical industry.
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
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
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
Vimachem
Founded
2014
Country
United States
Website
www.vimachem.com
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
No
Forecasting
No
Quality Control
No
Quote Management
No
Resource Management
No
Supplier Management
No
Supply Chain Management
No
Traceability
No