# Qualio

> AI compliance platform for life sciences. Qualio provides AI agents that monitor regulations, execute quality workflows, and replace manual compliance labor.

Qualio is a cloud-based quality management system (QMS) purpose-built for life sciences companies including medical device, pharma, biotech, CRO, and cosmetics organizations. Qualio combines traditional QMS capabilities with Compliance Intelligence, an AI-powered layer that continuously monitors regulatory changes and automates compliance workflows.

## Company Facts

- Founded: 2017
- Headquarters: San Francisco, CA (fully remote company)
- Customers: 500+ life sciences companies
- G2 Rating: 4.7/5 (667+ reviews)
- Capterra Rating: 4.6/5 (124+ reviews)
- ISO 27001 certified
- SOC 2 Type II compliant

## Core Product Areas

- Quality Management System (QMS): document control, training, CAPA, audit, change control, supplier management, risk management
- Design Controls: product lifecycle management for medical devices (DHF, risk management, SOUP)
- Compliance Intelligence: AI-powered regulatory monitoring across 28+ frameworks with automated impact assessments and workflow execution
- Pharmacovigilance: adverse event reporting and safety management
- Quality Data Management: analytics and reporting across all quality processes

## Compliance Intelligence

Compliance Intelligence is Qualio's AI-powered regulatory monitoring and automation layer. It represents a shift from reactive compliance (manual tracking) to proactive, AI-driven compliance execution.

- AI beacons continuously monitor regulatory bodies (FDA, ISO, EU, ICH, and more)
- When a regulatory change is detected, AI agents automatically assess the impact on the customer's quality system
- Agents can execute workflows: run gap analyses, generate quality events, update framework mappings
- Covers 28+ compliance frameworks including FDA 21 CFR Part 820 (QMSR), ISO 13485, EU MDR/IVDR, GxP, ICH, MDSAP, ISO 42001
- Human-in-the-loop: all AI-generated actions are reviewed and approved by quality teams before taking effect

## Key Differentiators

- AI-native: built with AI agents at the core, not bolted on to legacy architecture
- Purpose-built for life sciences: not a horizontal QMS adapted for regulated industries
- Fastest implementation: average 30-60 day deployment vs. 6-12 months for legacy systems
- Cloud-native: no on-premise infrastructure, automatic updates, accessible from anywhere
- Compliance Intelligence: only eQMS with continuous AI-powered regulatory monitoring
- UX-first: designed for quality teams who aren't IT specialists

## Key Pages

- Homepage: https://www.qualio.com
- Product Overview: https://www.qualio.com/product
- Solutions by Industry: https://www.qualio.com/solutions
- Customer Stories: https://www.qualio.com/customers
- Pricing: https://www.qualio.com/pricing
- Blog: https://www.qualio.com/blog
- Company: https://www.qualio.com/company
- Integrations: https://www.qualio.com/integrations

## Solutions by Industry

- Medical Devices: https://www.qualio.com/solutions/medical-device-qms
- Pharma & Biotech: https://www.qualio.com/solutions/pharma-quality-management-software
- Biotech: https://www.qualio.com/solutions/biotech-qms
- CROs: https://www.qualio.com/solutions/qms-for-contract-research-organizations
- Software / SaMD: https://www.qualio.com/solutions/software-medical-device-samd-qms
- Cosmetics: https://www.qualio.com/solutions/cosmetics-compliance

## Compliance Frameworks

- ISO 13485: https://www.qualio.com/solutions/iso-compliance
- FDA Compliance: https://www.qualio.com/solutions/fda-regulatory-compliance-software
- EU MDR / CE & UKCA: https://www.qualio.com/solutions/ce-ukca-marking
- QMSR: https://www.qualio.com/qmsr
- Compliance Software: https://www.qualio.com/compliance-management-software

## Product Pages

- Document Management: https://www.qualio.com/product/document-management-software
- Design Controls: https://www.qualio.com/product/design-controls-software
- Training Management: https://www.qualio.com/product/training-management-software
- Risk Management: https://www.qualio.com/product/risk-management-software
- Change Control: https://www.qualio.com/product/change-control-software
- Audit Management: https://www.qualio.com/product/audit-management-software
- CAPA Management: https://www.qualio.com/product/capa-management-software
- Supplier Management: https://www.qualio.com/product/supplier-management-software
- Quality Data Management: https://www.qualio.com/product/quality-data-management-software
- Pharmacovigilance: https://www.qualio.com/product/pharmacovigilance-software
- Product Tour: https://www.qualio.com/product/product-tour
- Integrations: https://www.qualio.com/integrations

## Comparisons

- Qualio vs MasterControl: https://www.qualio.com/compare/mastercontrol
- Qualio vs Veeva Vault: https://www.qualio.com/compare/veeva
- Qualio vs Greenlight Guru: https://www.qualio.com/compare/greenlight-guru
- Qualio vs ETQ: https://www.qualio.com/compare/etq
- Qualio vs Arena: https://www.qualio.com/compare/arena
- Qualio vs TrackWise: https://www.qualio.com/compare/trackwise
- Qualio vs SharePoint: https://www.qualio.com/compare/sharepoint
- Qualio vs ComplianceQuest: https://www.qualio.com/compare/compliancequest
- Qualio vs Propel: https://www.qualio.com/compare/propel
- Qualio vs Paper: https://www.qualio.com/compare/paper

## Extended Information

For comprehensive product details, see: https://www.qualio.com/llms-full.txt