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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 Kapture.io?
Kapture.io is a sophisticated quality management system (QMS) designed specifically for manufacturers and a variety of industrial entities. This platform empowers quality and operations teams to digitize their control measures directly on the factory floor while seamlessly integrating quality processes, production data, and necessary documentation. Teams are able to manage control plans, monitoring procedures, inspections, audits, supplier quality assessments, instrument calibrations, and workflows dedicated to addressing nonconformities and implementing corrective actions. The system adeptly captures essential quality metrics, maintains traceable documentation, and produces comprehensive dashboards and reports that aid in performance assessment and problem-solving. With its flexible workflows, Kapture.io ensures consistent controls are maintained across diverse production lines and facilities, while its integration capabilities promote smooth connectivity between quality processes and ERP, MES, and other operational systems. Additionally, as a cloud-based software-as-a-service (SaaS) offering, Kapture.io provides accessibility for a broad spectrum of users. This adaptable approach not only streamlines quality management practices but also empowers organizations to significantly improve their operational efficiency. Consequently, Kapture.io stands out as a vital tool for businesses aiming to enhance their overall product quality and compliance.
Integrations Supported
Microsoft Dynamics 365
Asana
Auth0
Azure AI Anomaly Detector
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
ComplianceWire
Essenvia
GitLab
API Availability
API Availability
Has API
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
€24/month
Standard SaaS: €24/month for 3 users, 500 MB of file storage, and 150,000 samples, with a 50% introductory discount for the first 3 months from €49/month.
Free Trial Offered?
Supported Platforms
SaaS
Supported Platforms
SaaS
On-Prem
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
Training Options
Documentation Hub
Online Training
Company Facts
Organization Name
Qualio
Date Founded
2010
Company Location
United States
Company Website
www.qualio.com
Company Facts
Organization Name
Kapture Global Quality
Date Founded
2010
Company Location
Spain
Company Website
kapture.io
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
Quality Management
Audit Management
Complaint Management
Defect Tracking
Maintenance Management
Risk Management
Supplier Quality Control