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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

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.

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

Small and growing businesses in Life Sciences & Healthcare

Audience

Laboratories and companies in need of a SCIP reporting solution for maintaining material data and export compliance

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

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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Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Qualio
Founded: 2010
United States
www.qualio.com

Company Information

Substantio
Germany
substantio.com

Alternatives

Propel

Propel

Propel Software

Alternatives

Rumzer

Rumzer

Rumzer Compliance Software
isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd
GreenCheck Software

GreenCheck Software

APA Engineering
QT9 QMS

QT9 QMS

QT9 Software

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

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

Integrations

Auth0
Azure AI Anomaly Detector
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
GitLab
GitLab Duo
Intercom
Jira
Microsoft 365
Microsoft Dynamics 365
RegDesk
SSOJet
Salesforce
TestRail
Xray

Integrations

Auth0
Azure AI Anomaly Detector
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
GitLab
GitLab Duo
Intercom
Jira
Microsoft 365
Microsoft Dynamics 365
RegDesk
SSOJet
Salesforce
TestRail
Xray
Claim Substantio and update features and information
Claim Substantio and update features and information