CLEEN

CLEEN

Leucine
Nova-Cleaning Validation

Nova-Cleaning Validation

Novatek International
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About

CLEEN, a proactive cleaning validation software trusted by Fortune 500 Pharma, is a global leader for digitalizing cleaning compliance procedures. CLEEN is implemented at some of the best pharma companies across the globe and has played a significant role in resolving regulatory observations and setting a gold standard for cleaning validation. CLEEN, a preferred choice of regulators, brings accuracy, consistency & harmonization in Cleaning Procedures end-to-end.

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.

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 Industry

Audience

Pharmaceutical manufacturers looking for a powerful Manufacturing solution

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

Leucine
Founded: 2015
United States
www.leucinetech.com

Company Information

Novatek International
Founded: 1996
Canada
www.ntint.com

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FactoryTalk PharmaSuite

FactoryTalk PharmaSuite

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Categories

Categories

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Manufacturing Features

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

Integrations

FactoryTalk
SAP Cloud Platform
SAP ERP
TrackWise

Integrations

FactoryTalk
SAP Cloud Platform
SAP ERP
TrackWise
Claim CLEEN and update features and information
Claim CLEEN and update features and information
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