Nova-Cleaning ValidationNovatek International
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RiskMachSotersoft
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Related Products
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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.
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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.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Pharmaceutical manufacturers looking for a powerful Manufacturing solution
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Audience
Organizations in need of a solution to keep their inspections, audits and risk assessments organized
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationNovatek International
Founded: 1996
Canada
www.ntint.com
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Company InformationSotersoft
United Kingdom
www.riskmach.co.uk
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Categories |
Categories |
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Manufacturing Features
Accounting Integration
ERP
Maintenance Management
MES
MRP
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management
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Integrations
No info available.
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Integrations
No info available.
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