Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Switch Automation No 

Integrations

Switch Automation Yes 

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) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

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 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

Manufacturing Execution

Document Management No 
Forecasting No 
Quality Control No 
Quote Management No 
Resource Management No 
Supplier Management No 
Supply Chain Management No 
Traceability No 

Alternatives

CaliberBRM Reviews

CaliberBRM

Caliber Technologies

Alternatives

V5 Traceability Reviews

V5 Traceability

SG Systems Global
anicomply Reviews

anicomply

anic GmbH
Laurel MES Reviews

Laurel MES

Laurus Infosystems
QT9 ERP  Reviews

QT9 ERP

QT9 Software
MOM4 Reviews

MOM4

NearSoft