Qualio
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What is Qualio?
Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk.
With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive.
Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box.
Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand.
The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
What is EPR Scan?
EPR Scan functions as a compliance verification tool tailored specifically for ecommerce sellers who are dispatching packaged goods to the European Union, adhering to a defined set of guidelines. It aids users in capturing crucial information such as shipping destinations, sales avenues, dispatch and storage routes, seller responsibilities, packaging duties, and product details. The assessment framework guarantees that this information is systematically categorized by route and country while also monitoring any unidentified or unsupported items for later review, connecting outcomes to official regulations and the particular version of the ruleset in use. Furthermore, Shopify merchants can evaluate the numbers of EU destinations and SKU counts from their latest orders, generate a report relevant to their country, and retrieve past reports within the Shopify Admin interface. A complimentary check for EU-27 can be accessed without the need for account creation, and there is also an optional paid evidence report available for one to three selected countries. It is crucial to understand that while EPR Scan delivers general compliance insights, it is not intended as legal counsel, making it essential for users to recognize their obligations in upholding compliance. This tool ultimately acts as an indispensable aid for ecommerce sellers as they navigate the intricate landscape of EU packaging laws while ensuring they remain informed about their compliance duties.
Media
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Integrations Supported
Asana
Auth0
Azure AI Anomaly Detector
Azure DevOps
Azure DevOps Server
Azure-AD-External-Identities
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
API Availability
API Availability
Pricing Information
Qualio 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.
Pricing Information
€79/report
The EU-27 check and country CSV are free. The optional evidence report costs €79 per purchase for 1–3 supported countries, before applicable tax. Shopify-billed charges are processed in USD. There is no subscription.
Free Version
Supported Platforms
SaaS
Supported Platforms
SaaS
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
Training Options
Documentation Hub
Company Facts
Organization Name
Qualio
Date Founded
2010
Company Location
United States
Company Website
www.qualio.com
Company Facts
Organization Name
YAS
Date Founded
2025
Company Location
Poland
Company Website
eprscan.eu
Categories and Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
Risk Management
Version Control
Workflow / Process Automation
Electronic Batch Records (EBR)
Not specified
ISO Compliance
Not specified
Life Sciences
Not specified
Medical Quality Management Systems
Not specified
Pharmacovigilance
Not specified
Policy Management
Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management
Product Compliance
Not specified
Quality Management
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
Categories and Features
Product Compliance
Not specified