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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

All your inspections, audits, and risk evaluations can be streamlined in a single location, even when collaborating with both internal and external service professionals. Our all-encompassing system enables the essential components of the Design Risk Assessment—information gathering, risk analysis, and risk evaluation—to be systematically organized and updated as new data emerges. RiskMach serves as a unified platform, allowing individuals with varying degrees of technical expertise to participate in the Design Risk Assessment phase of the product self-certification process, thereby ensuring that every possible risk is thoroughly considered. With our intuitive platform, you will never overlook a crucial document in your technical file! Each participant in the CE process will have the capability to request and exchange documents seamlessly, ensuring that all necessary information is compiled for the technical file required for your UKCA or CE certification. This collaborative approach not only enhances efficiency but also promotes a thorough understanding of potential risks among all team members.

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

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

Sotersoft

Country

United Kingdom

Website

www.riskmach.co.uk

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

Fixed Asset Management

Asset Budgeting
Asset Lifecycle Management
Audit Trail
Barcoding / RFID
Depreciation Management
Disposal Management
Document Management
Inventory Tracking
Tax Management

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