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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

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

Screenshots View All

Screenshots View All

Integrations

Switch Automation

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

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