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Average Ratings 0 Ratings

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features
design
support

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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

SG Systems Global offers traceability and manufacturing solutions for regulated and non-regulated industries, integrating with ERP and MES platforms to boost efficiency and ensure product quality. Key Modules: * Electronic Batch Records (EBRs): Digital records to meet 21 CFR Part 11 and GMP compliance, reducing manual errors. * Formula Control: Ensures accurate ingredient measurement and consistency across batches. * Batch Control: Tracks production in real time, enabling lot validation and recall management. * Warehouse Management System (WMS): Manages inventory with barcode scanning and real-time stock updates. * Production Scheduling: Automates workflows, assigns tasks, and generates performance reports. These solutions streamline processes, enhance compliance, and support scalable growth for manufacturers.

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

SG Systems Global

Country

United States

Website

sgsystemsglobal.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

Food Manufacturing

Compliance
ERP
Food Safety
Food Traceability
Ingredient Management
Production Scheduling
Quality Management
Recall Tracking
Recipe Management
Seasonal Demand Forecasting
Supply Chain Management

Food Traceability

CRM
Order Management
Product Lifecycle Management
Production Management
Quality Control
Recall Management
Recipe Management
Traceability
Traceback & Traceforward

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