CLEENLeucine
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Related Products
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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.
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About
Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences. It drafts IQ/OQ/PQ protocols, GAMP 5 classifications and audit trails straight from source documents (URS, P&IDs, SOP libraries), with every requirement traced end-to-end through a queryable graph that replaces spreadsheet RTMs. All ALCOA+ data-integrity criteria are monitored on every record, not samples, with humans reviewing and approving agent output. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others). Built for Heads of Validation and validation consultancies at pharma, biotech and medical-device companies. Annual per-site licence, quoted on request; an 8-12 week fixed-fee pilot (one system) is available.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Supported
iPad
Not Supported
Android
Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Pharmaceutical Industry
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Audience
Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Not Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Not Supported
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API
Offers API
Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and VideosNo images available
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Pricing
No information available.
Free Version
Supported
Free Trial
Supported
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Not Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Company InformationLeucine
Founded: 2015
United States
www.leucinetech.com
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Company InformationQualitum
qualitum.ai
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Categories |
Categories |
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Compliance Features
Archiving & Retention
Supported
Artificial Intelligence (AI)
Not Supported
Audit Management
Supported
Compliance Tracking
Supported
Controls Testing
Supported
Environmental Compliance
Not Supported
FDA Compliance
Supported
HIPAA Compliance
Not Supported
Incident Management
Supported
ISO Compliance
Supported
OSHA Compliance
Not Supported
Risk Management
Supported
Sarbanes-Oxley Compliance
Not Supported
Surveys & Feedback
Not Supported
Version Control
Supported
Workflow / Process Automation
Supported
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Integrations
FactoryTalk
Supported
SAP Cloud Platform
Supported
SAP ERP
Supported
TrackWise
Supported
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Integrations
FactoryTalk
Not Supported
SAP Cloud Platform
Not Supported
SAP ERP
Not Supported
TrackWise
Not Supported
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