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Average Ratings 0 Ratings

Total
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

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

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

Vimachem

Founded

2014

Country

United States

Website

www.vimachem.com

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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