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What is Siemens Opcenter Execution Pharma?

Siemens Digital Industries Software has unveiled Opcenter Execution Pharma, which was formerly known as "SIMATIC IT eBR," and is designed as a dedicated MES solution for the pharmaceutical industry, enabling fully paperless manufacturing and thorough electronic batch recording. This cutting-edge platform features advanced functionalities for the design, optimization, and management of both manual and automated production processes, enabled by its seamless connectivity with MES, automation, and enterprise resource planning (ERP) systems. By maximizing the efficiency of diverse manufacturing resources—including equipment, personnel, processes, and products—Opcenter Execution Pharma is instrumental in driving productive operations. It provides real-time insights into manufacturing execution and grants access to essential process and quality information, thus facilitating the improvement of production workflows from the initial order to the finished product. Furthermore, this solution not only enhances operational efficiency but also ensures adherence to rigorous industry standards and regulations, ultimately fostering a culture of quality and compliance within the pharmaceutical sector. As a result, manufacturers can achieve higher levels of productivity while maintaining the integrity of their processes.

What is Nova-Cleaning Validation?

Nova-Cleaning Validation software is essential for enhancing product integrity by adeptly handling changes and assessing the risks related to cross-contamination and impurities in a dynamic production environment. It diligently examines every modification concerning methods, APIs, products, equipment, and family groups to maintain product integrity while ensuring compliance with regulatory requirements. In addition, Nova-Cleaning Validation complies with the stipulations outlined in 21 CFR Part 11 and EU Annex 11, which further solidifies its reliability. The system utilizes a risk-based approach and is thoroughly designed in accordance with PDA Technical Reports 29 and 49, ISPE MaPP, and 21 CFR Part 211.67, positioning it as a trusted option for quality assurance in the pharmaceutical sector. This all-encompassing strategy not only protects product quality but also boosts the overall efficiency of the manufacturing process, ultimately leading to more reliable outcomes for stakeholders. By continuously adapting to new challenges in the industry, it ensures that the highest standards of quality are consistently met.

Media

Media

Integrations Supported

Switch Automation

Integrations Supported

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Windows
Mac

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Siemens

Date Founded

1847

Company Location

Germany

Company Website

www.plm.automation.siemens.com/global/en/products/manufacturing-operations-center/simatic-it-ebr.html

Company Facts

Organization Name

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

www.ntint.com

Categories and Features

Categories and Features

Manufacturing

Quality Management
Reporting/Analytics

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