Company Website
Company Website

Ratings and Reviews 823 Ratings

Ratings and Reviews 18 Ratings

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 AlisQI?

AlisQI is a quality management platform for process and batch manufacturers who want to bring more structure, visibility, and control to their operations, without turning quality into a separate administrative burden. Many quality systems focus on documents and events after the fact. AlisQI takes a different approach by connecting quality, lab, and production data into a shared operational context. This makes it easier for teams to understand what is happening in real time, identify emerging issues, and respond before problems escalate. The platform consists of a set of modular quality capabilities, covering areas such as document control, training management, deviations, CAPA, audits, risk management, supplier quality, statistical process control, and EHS. These modules are combined into ready-to-use solutions, called Solvers, that address specific quality and operational challenges in day-to-day manufacturing. Solvers are designed to work from the start and adapt as products, processes, or sites evolve. Changes can be made without custom development, external consultants, or disruptive IT projects, allowing manufacturers to improve continuously while staying compliant by default. AlisQI is used by manufacturing companies across multiple industries to reduce firefighting, improve consistency across sites, and support stable, predictable operations.

Media

Media

Integrations Supported

Microsoft Dynamics 365
Asana
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Essenvia
GROW with SAP
GitHub Advanced Security
GitLab
Google Cloud Operations Suite
HubSpot CRM
Jira
Microsoft 365
Microsoft OneDrive
NetSuite
Okta
TestRail
Zephyr

Integrations Supported

Microsoft Dynamics 365
Asana
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Essenvia
GROW with SAP
GitHub Advanced Security
GitLab
Google Cloud Operations Suite
HubSpot CRM
Jira
Microsoft 365
Microsoft OneDrive
NetSuite
Okta
TestRail
Zephyr

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$1000 per month
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
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

AlisQI

Date Founded

2002

Company Location

Netherlands

Company Website

www.AlisQI.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
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Policy Management

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

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

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

LIMS

Audit Trail
Certificates of Analysis
Data Import / Export
Electronic Laboratory Notebook
Inventory Management
Lab Instrument Interface
Reporting & Statistics
Sample Tracking
Specification Management
Workflow Management

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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