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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 Isolocity?

Isolocity serves as a comprehensive solution for cannabis compliance with ISO 9001 and GMP standards in the industry. Our software effectively integrates GMP principles with the management and documentation processes of your production. Designed specifically with GMP standards in mind, Isolocity's compliance software features various modules that are crucial for enhancing safety and increasing yield within your facility, thereby facilitating certification. By automating labor-intensive tasks, Isolocity simplifies the process of achieving ISO 9001:2015 compliance. Our QMS software not only aids in maintaining consistency in production but also assists you throughout the ISO 9001 certification journey. Additionally, Isolocity’s risk management module encompasses HACCP planning and PFMEA, enabling you to efficiently plan, initiate, prioritize, and monitor actions aimed at reducing potential failures and hazards in production. With a user-friendly, tablet-optimized interface, you can manage inspections and furnish quality managers with real-time reports. Furthermore, Isolocity ensures complete traceability from customer to supplier, fostering transparency and accountability throughout the supply chain. This comprehensive approach not only enhances operational efficiency but also promotes a culture of continuous improvement within your organization.

Media

Media

Integrations Supported

Asana
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
ComplianceWire
GitHub
GitLab
Google Cloud Operations Suite
HubSpot CRM
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
RegDesk
SSOJet
TestRail
Xray
Zephyr

Integrations Supported

MJ Platform

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

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
iPhone
iPad

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
On-Site Training

Company Facts

Organization Name

Qualio

Date Founded

2010

Company Location

United States

Company Website

www.qualio.com

Company Facts

Organization Name

Isolocity

Date Founded

2015

Company Location

Canada

Company Website

www.isolocity.com

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

ISO Compliance

Not specified

Life Sciences

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

Cannabis

Administrative / HR Management
Business Management
Compliance Tracking
Cultivation Management
Delivery Management
For Hemp & CBD
Inventory Management / Control
Manufacturing
Reporting / Analytics
Supplier Management
Supply Chain Management
Traceability

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

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