Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
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