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
Siemens Digital Industries Software has introduced Opcenter Execution Pharma, previously referred to as "SIMATIC IT eBR," which is a specialized MES solution tailored for the pharmaceutical sector, facilitating entirely paperless production and comprehensive electronic batch recording. This innovative platform boasts sophisticated capabilities for designing, refining, and overseeing both manual and automated production activities, achieved through seamless integration with MES, automation, and enterprise resource planning (ERP) systems. By optimizing the utilization of various manufacturing resources—such as equipment, personnel, processes, and products—Opcenter Execution Pharma plays a crucial role in promoting efficient production. It delivers real-time insights into manufacturing execution along with access to process and quality information, thereby aiding in the enhancement of production workflows from the initial order stage to the final product. Ultimately, this solution not only improves operational efficiency but also supports compliance with stringent industry regulations.
API Access
Has API
API Access
Has API
Integrations
Switch Automation
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
Siemens
Founded
1847
Country
Germany
Website
www.plm.automation.siemens.com/global/en/products/manufacturing-operations-center/simatic-it-ebr.html
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