Qualio Reviews

Qualio

4.4 out of 5 stars
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Average Ratings 919 Ratings

Description

EPR Scan is a compliance checker designed for ecommerce sellers who are shipping packaged products to the European Union, operating under a set of established rules. It assists users in documenting essential details such as destinations, sales channels, routes for dispatch and storage, seller roles, packaging responsibilities, and product specifications. The evaluation process ensures that these details are clearly organized by route and country while also keeping track of any unknown or unsupported items for future examination, linking findings to official regulations and the specific ruleset version utilized. Additionally, Shopify merchants have the capability to analyze EU destination counts and SKU quantities from their most recent orders, export a summary pertinent to their country, and access previously purchased reports in the Shopify Admin. A free check for EU-27 is available without needing to create an account, while an optional paid evidence report can be acquired for one to three chosen countries. It is important to note that EPR Scan offers general compliance information and should not be interpreted as legal advice, ensuring that users are aware of their responsibilities in maintaining compliance. Overall, this tool serves as a vital resource for ecommerce sellers navigating the complexities of EU packaging regulations.

Description

Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness. Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards. Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams. Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations. The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

No images available

Screenshots View All

Integrations

Azure DevOps Labs No 
Azure DevOps Server No 
Dynamics 365 Customer Service No 
Essenvia No 
GitHub No 
GitHub Advanced Security No 
GitLab No 
GitLab Duo No 
HubSpot CRM No 
Intercom No 
Microsoft 365 No 
Microsoft OneDrive No 
Okta No 
RegDesk No 
SSOJet No 
Salesforce No 
Shopify Yes 
TestRail No 
Xray No 
Zephyr No 

Integrations

Azure DevOps Labs Yes 
Azure DevOps Server Yes 
Dynamics 365 Customer Service Yes 
Essenvia Yes 
GitHub Yes 
GitHub Advanced Security Yes 
GitLab Yes 
GitLab Duo Yes 
HubSpot CRM Yes 
Intercom Yes 
Microsoft 365 Yes 
Microsoft OneDrive Yes 
Okta Yes 
RegDesk Yes 
SSOJet Yes 
Salesforce Yes 
Shopify No 
TestRail Yes 
Xray Yes 
Zephyr Yes 

Pricing Details

€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 Trial No 
Free Version Yes 

Pricing Details

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.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

YAS

Founded

2025

Country

Poland

Website

eprscan.eu

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

Product Features

Product Features

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) Yes 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing Yes 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance No 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation Yes 

Policy Management

Approval Process Control Yes 
Attestation Yes 
Audit Trails Yes 
Policy Creation Yes 
Policy Library Yes 
Policy Metadata Management Yes 
Policy Training Yes 
Reporting / Analytics Yes 
Version Control Yes 
Workflow Management Yes 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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