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
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
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
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
No
Webinars
No
Live Training (Online)
No
In Person
No
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
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
Food Manufacturing
Compliance
No
ERP
No
Food Safety
No
Food Traceability
No
Ingredient Management
No
Production Scheduling
No
Quality Management
No
Recall Tracking
No
Recipe Management
No
Seasonal Demand Forecasting
No
Supply Chain Management
No
Food Traceability
CRM
No
Order Management
No
Product Lifecycle Management
No
Production Management
No
Quality Control
No
Recall Management
No
Recipe Management
No
Traceability
No
Traceback & Traceforward
No