Impurity Profiling SuiteACD/Labs
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Nova-Cleaning ValidationNovatek International
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Related Products
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About
Predict genotoxic & carcinogenic endpoints of impurities and degradants to meet ICH M7 guidelines. Impurity Profiling Suite can be used as part of your ICH M7 workflow—to help prepare regulatory submissions and remain compliant.
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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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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
Chemists
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Audience
Pharmaceutical manufacturers looking for a powerful Manufacturing solution
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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 InformationACD/Labs
Founded: 1994
Canada
www.acdlabs.com/products/percepta-platform/impurity-profiling-suite/
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Company InformationNovatek International
Founded: 1996
Canada
www.ntint.com
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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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