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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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

$395 one-time payment
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 No 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
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 No 
Live Training (Online) No 
In Person No 

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 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

Environmental

Air Management Yes 
Auditing No 
Compliance Management No 
Document Management No 
Emissions Inventory No 
Hazardous Materials Control No 
Sustainability Management Yes 
Training Management No 
Waste Management No 
Water Management Yes 

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