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
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
Laboratories and companies in need of a SCIP reporting solution for maintaining material data and export compliance
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Not Supported
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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
Not Supported
In Person
Not Supported
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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 |
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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
Supported
Azure DevOps Labs
Supported
Azure DevOps Server
Supported
Dynamics 365 Customer Service
Supported
GitHub Desktop
Supported
GitLab
Supported
GitLab Duo
Supported
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Integrations
Asana
Not Supported
Azure AI Anomaly Detector
Not Supported
Azure AI Document Intelligence
Not Supported
Azure DevOps
Not Supported
Azure DevOps Labs
Not Supported
Azure DevOps Server
Not Supported
Dynamics 365 Customer Service
Not Supported
GitHub Desktop
Not Supported
GitLab
Not Supported
GitLab Duo
Not Supported
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