Nova-Cleaning Validation

Nova-Cleaning Validation

Novatek International
RiskMach

RiskMach

Sotersoft
+
+

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About

Nova-Cleaning Validation software significantly enhances product integrity by managing changes and assessing the risks associated with cross-contamination and product impurities within a dynamic production environment. All changes to methods, APIs, products, equipment, and family groups are automatically evaluated to ensure product integrity and regulatory compliance. Nova-Cleaning Validation complies with 21 CFR Part 11 and EU Annex 11. The system uses a risk-based approach and is designed based on PDA Technical Reports 29 and 49, ISPE MaPP, 21 CFR Part 211.67.

About

You can have all your inspections, audits and risk assessments organized in one place, even if you use a mix of internal and external professional service providers. Thanks to our comprehensive system, the three key parts of the Design Risk Assessment: information gathering, risk analysis and risk evaluation can be organized and kept track of as new information comes to light. RiskMach is a common platform where multiple people with various levels of technical knowledge can contribute to the Design Risk Assessment stage of product self-certification, ensuring that all potential risks have been addressed. Never miss an important document in your technical file! With our easy-to-use platform, everyone involved in the CE process will be able to request and share documents to compile all the information needed to complete the technical file that goes with your UKCA or CE certification.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Pharmaceutical manufacturers looking for a powerful Manufacturing solution

Audience

Organizations in need of a solution to keep their inspections, audits and risk assessments organized

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Novatek International
Founded: 1996
Canada
www.ntint.com

Company Information

Sotersoft
United Kingdom
www.riskmach.co.uk

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Categories

Categories

Manufacturing Features

Accounting Integration
ERP
Maintenance Management
MES
MRP
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management

Integrations

No info available.

Integrations

No info available.
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