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
The increasing number of regulations that companies have to adapt and fulfill are making life difficult and the overall topic becomes more and more complex. Substantio Software & Substantio Services are helping to define & implement an effective Substance Compliance process. Our team is working in the Substance Compliance domain for many years. A variety of successful customer projects led to best-practice approaches that we are continuously developing further to deliver best-in-class solutions. Report to SCIP with one click. The Substantio software and our experienced team will help you set up the ECHA account, configure S2S access and import your data into Substantio. After this first step, Substantio does everything automatically, you just need to select the parts you want to submit. Substantio automatically validates the entered data according to the most common regulations like RoHS, REACH or Proposition 65, and many others.
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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
Small and growing businesses in Life Sciences & Healthcare
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Audience
Laboratories and companies in need of a SCIP reporting solution for maintaining material data and export compliance
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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 InformationQualio
Founded: 2010
United States
www.qualio.com
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Company InformationSubstantio
Germany
substantio.com
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Alternatives |
Alternatives |
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Categories |
Categories |
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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
Policy Management Features
Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management
Quality Management Features
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
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Integrations
Auth0
Azure AI Anomaly Detector
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
GitLab
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Integrations
Auth0
Azure AI Anomaly Detector
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
GitLab
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