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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

Werum's PAS-X offers a well-established software solution tailored for the highly regulated and batch-focused process industries. This MES delivers comprehensive built-in functionality for various applications within the pharmaceutical and biopharmaceutical domains. Organizations that utilize PAS-X experience enhanced operational efficiency and streamlined production processes. The software encompasses all essential features necessary for effective pharmaceutical and biopharmaceutical manufacturing right from the start. Meeting the stringent requirements of regulatory bodies, including the FDA, PAS-X ensures compliance and safety. Furthermore, its extensive array of standard interfaces facilitates quicker implementation and promotes smooth data exchange with adjacent IT and production systems. The PAS-X MES caters to all significant segments of the pharmaceutical industry, including the production of vaccines, biopharmaceuticals, solids, and liquids, among other manufacturing activities. Ultimately, PAS-X empowers companies to achieve their operational goals while adhering to industry standards and regulations.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

SAP Cloud Platform
zenon

Integrations

SAP Cloud Platform
zenon

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

Werum IT Solutions

Founded

1969

Country

Germany

Website

www.werum.com/en/pas-x-mes/

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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