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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

The RBCA Tool Kit for Chemical Releases, version 2.6, has been designed to align with the ASTM Standard Guide for Risk-Based Corrective Action (E-2081), offering enhanced flexibility along with new risk and transport models to simplify the process of establishing risk-based clean-up levels for soil and groundwater in accordance with local regulations globally. As environmental site managers, regulatory bodies, and consultants increasingly adopt Risk-Based Corrective Action (RBCA) for addressing contaminated soil and groundwater, this approach emphasizes safeguarding human health and the environment while also facilitating cost-effective and efficient solutions that prioritize resources for the most hazardous locations. By integrating these new models, the tool kit not only streamlines the clean-up process but also supports a broader range of applications, making it a vital resource in the fight against environmental contamination.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$395 one-time payment
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

GSI Environmental

Website

www.gsi-net.com

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

Environmental

Air Management
Auditing
Compliance Management
Document Management
Emissions Inventory
Hazardous Materials Control
Sustainability Management
Training Management
Waste Management
Water Management

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