Learn More
Learn More

Average Ratings 108 Ratings

Average Ratings 919 Ratings

Description

AlisQI is a cloud-based Quality Management platform built for process and batch manufacturers who want to move beyond reactive firefighting toward stable, predictable operations while maintaining full compliance control. Rather than organizing quality around static documents and isolated events, AlisQI was designed as a data-first system. Quality, laboratory, and production data are structured and connected in a shared operational backbone. This gives cross-functional teams early visibility into deviations, faster response times, and greater confidence in product integrity and daily execution. The platform combines configurable quality modules, including document control, training, deviations, CAPA, audits, risk management, supplier quality, SPC, and EHS, with targeted, ready-to-use Solvers. Solvers integrate forms, workflows, dashboards, and business logic to address specific operational problems without unnecessary scope. Because the system is built on structured data, manufacturers can apply practical AI within workflows, from automated COA extraction to conversational access to quality data and pattern detection across incidents. Solvers are production-ready from day one and evolve as processes, products, or plants change. This progression does not require custom development or disruptive IT projects. Manufacturers use AlisQI to harmonize quality practices across sites, reduce waste and rework, strengthen audit readiness, accelerate root cause analysis, and connect shop-floor and lab data directly to quality decision-making across industries including chemicals, plastics, packaging, food and beverage, personal care, automotive, and industrial manufacturing.

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 Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Microsoft Dynamics 365 Yes 
Azure DevOps No 
Azure DevOps Server No 
Azure-AD-External-Identities No 
ComplianceWire No 
Dynamics 365 Customer Service No 
GROW with SAP Yes 
GitHub Desktop No 
GitLab Duo No 
Google Cloud Operations Suite No 
HubSpot CRM No 
Jira No 
Microsoft 365 No 
Microsoft OneDrive No 
Microsoft Power Automate Yes 
Okta No 
SSOJet No 
Salesforce No 
TestRail No 
Workato Yes 

Integrations

Microsoft Dynamics 365 Yes 
Azure DevOps Yes 
Azure DevOps Server Yes 
Azure-AD-External-Identities Yes 
ComplianceWire Yes 
Dynamics 365 Customer Service Yes 
GROW with SAP No 
GitHub Desktop Yes 
GitLab Duo Yes 
Google Cloud Operations Suite Yes 
HubSpot CRM Yes 
Jira Yes 
Microsoft 365 Yes 
Microsoft OneDrive Yes 
Microsoft Power Automate No 
Okta Yes 
SSOJet Yes 
Salesforce Yes 
TestRail Yes 
Workato No 

Pricing Details

$1000 per month
Pricing starts from around $1,000 per month for a single site and is based on the Solvers you select. Manufacturers can start with only the Solvers they need to address their most urgent quality or operational challenges, then add more over time as needs evolve. Pricing is per site with unlimited users, allowing teams to scale usage without unexpected per-user costs.
Free Trial No 
Free Version No 

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 Yes 
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) Yes 
In Person Yes 

Types of Training

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

Vendor Details

Company Name

AlisQI

Founded

2002

Country

Netherlands

Website

www.AlisQI.com

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

Product Features

CAPA

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

LIMS

Audit Trail Yes 
Certificates of Analysis Yes 
Data Import / Export Yes 
Electronic Laboratory Notebook No 
Inventory Management No 
Lab Instrument Interface Yes 
Reporting & Statistics Yes 
Sample Tracking Yes 
Specification Management 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 

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 

Alternatives

Alternatives

Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
Propel Reviews

Propel

Propel Software
QT9 QMS Reviews

QT9 QMS

QT9 Software
isoTracker Quality Management Reviews

isoTracker Quality Management

isoTracker Solutions Ltd