cubeSAFETYCRScube
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About
Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health.
With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems.
What Qualio delivers:
✔️ Audit ready in weeks
✔️ Inspection ready anytime — no fire drills
✔️ Faster market entry
✔️ Lower total cost of compliance
✔️ Confident, risk-managed scaling
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About
cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Small and growing businesses in Life Sciences & Healthcare
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Audience
Safety-pharmacovigilance teams in pharma, biotech or device companies interested in a tool for adverse-event monitoring, reporting, and safety-case management
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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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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PricingQualio offers transparent, subscription-based pricing that scales with your users and needs. No hidden fees or per-module charges. Growth-stage companies benefit from fast time-to-value and significantly lower total cost of ownership than legacy platforms or consultant-heavy implementations. Contact us for a custom quote.n.
Free Version
Not Supported
Free Trial
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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
Not Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
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Company InformationQualio
Founded: 2010
United States
www.qualio.com
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Company InformationCRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety
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Alternatives |
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Categories |
Categories |
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Compliance Features
Archiving & Retention
Supported
Artificial Intelligence (AI)
Supported
Audit Management
Supported
Compliance Tracking
Supported
Controls Testing
Supported
Environmental Compliance
Supported
FDA Compliance
Supported
HIPAA Compliance
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
Policy Management Features
Approval Process Control
Supported
Attestation
Supported
Audit Trails
Supported
Policy Creation
Supported
Policy Library
Supported
Policy Metadata Management
Supported
Policy Training
Supported
Reporting / Analytics
Supported
Version Control
Supported
Workflow Management
Supported
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
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Integrations
Asana
Supported
Azure AI Anomaly Detector
Supported
Azure AI Document Intelligence
Supported
Azure DevOps Labs
Supported
Azure DevOps Server
Supported
Azure-AD-External-Identities
Supported
Essenvia
Supported
GitHub
Supported
GitHub Advanced Security
Supported
GitHub Desktop
Supported
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Integrations
Asana
Not Supported
Azure AI Anomaly Detector
Not Supported
Azure AI Document Intelligence
Not Supported
Azure DevOps Labs
Not Supported
Azure DevOps Server
Not Supported
Azure-AD-External-Identities
Not Supported
Essenvia
Not Supported
GitHub
Not Supported
GitHub Advanced Security
Not Supported
GitHub Desktop
Not Supported
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