What Qualio does

Qualio is a cloud-based, AI-powered electronic Quality Management System (eQMS) purpose-built for life sciences companies, founded in 2012 and headquartered in San Francisco with a European headquarters in Dublin, Ireland (legally Everworks Limited T/A Qualio). The platform unifies quality management, product lifecycle, and compliance intelligence in a single integrated system, serving 700+ customers across 80+ countries in medical devices, pharmaceuticals, biotech, cannabis, software as a medical device (SaMD), and contract research organizations. The product is modular, with core modules covering Documents, Design Controls, Risk Management, Training, Change Control, Audits, CAPAs and Non-Conformances, Suppliers, and Analytics, supplemented by Qualio Plus pre-built content (SOPs, policies, templates) and Qualio Validation Services built around FDA and GAMP guidance.

The technology foundation runs on AWS infrastructure and increasingly layers AI on top of the platform: Compliance Intelligence (launched October 2025) performs real-time gap detection and continuous monitoring across 28+ regulatory frameworks (FDA, ISO, EMA), while the Qualio AI Assistant (closed beta April 2025) provides natural language Q&A, document drafting, and compliance gap review. AI is delivered through AWS Bedrock using Anthropic's Claude and Amazon's Titan models, with customer data retained within Qualio's own AWS environment. The company itself is ISO 9001, ISO 27001, and ISO 27701 certified.

Commercially, Qualio operates an enterprise SaaS model with annual subscriptions invoiced in advance, custom quote-based pricing tied to organization size and feature scope, and a 20% commission partner referral channel (QA/RA consultancies and technology integrators) layered on top of direct enterprise sales. Revenue streams include platform subscription, professional services for onboarding and implementation, and licensing of Qualio Plus content. The company has raised over $60 million across eight funding rounds, with a $50 million Series B led by Tiger Global in May 2021, and is led by founder and CEO Robert Fenton with a globally distributed team of 51–100 employees.

Name

Qualio

Legal name

Everworks Limited T/A Qualio

Website

https://qualio.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

51–100 employees

Short description

Qualio is a cloud-based, AI-powered eQMS platform serving 700+ life sciences companies across 80+ countries with modular quality, product lifecycle, and compliance intelligence tools for medical devices, pharma, biotech, cannabis, SaMD, and CROs.

Ownership category

akta.pro rank

Product category

Life Sciences Quality Management Software

NAICS

Computer Systems Design Services (541512), Computer Systems Design and Related Services (54151)

SIC

Services-Computer Integrated Systems Design (7373)

akta.pro primary industry

Regulatory Readiness & Audit Automation (e.g., EU AI Act, NIST AI RMF, ISO/IEC 42001) (HDAAAMAE)

akta.pro secondary industries

AI Governance, Risk & Compliance (GRC) Platforms (HDAAAMAA), Enterprise AI Governance, Risk & Compliance Platforms (Model Risk, Audit, Policies) (HDAEANAE)

Keywords

• Quality management system
• Life sciences compliance
• Electronic quality management
• Regulatory compliance software
• AI compliance platform

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Infrastructure, Operations

Revenue model

1. SaaS Subscription - Platform Access: Time-specific license for customers to access and use the Qualio platform and services. Subscription fees are invoiced in advance and are non-refundable. Additional users can be purchased during subscription term at prorated rates.
2. Professional Services: Onboarding, implementation, and consulting/advisory services provided alongside the platform subscription as specified in Order Forms. Customer cooperation required for service delivery.
3. Qualio Plus (Pre-built Content): Optional add-on content package including policies, SOPs, work instructions, templates, and training materials. Customizable for customer use but cannot be resold.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels7 records

Core offering

Qualio offers a cloud-based AI-powered electronic Quality Management System (eQMS) purpose-built for life sciences companies. The platform unifies quality management, product lifecycle, and compliance intelligence through modules covering documents, design controls, risk management, training, change control, audits, CAPAs, suppliers, and analytics. It layers AI capabilities including Compliance Intelligence (real-time automated gap analysis across 28+ regulatory frameworks such as FDA, ISO, and EMA) and an AI Assistant for natural language interaction with QMS content.

Product overview

Qualio offers a unified AI-powered cloud-based eQMS platform for life sciences, combining quality management, product lifecycle, and compliance intelligence. The core platform includes modules for Documents, Design Controls, Risk Management, Training Management, Change Control, Audits, CAPAs & Non-Conformances, Suppliers, and Analytics. On top of this, Qualio layers AI capabilities through Compliance Intelligence (real-time gap detection and monitoring across 28+ regulatory frameworks) and AI Assistant (natural language interaction with QMS content). The platform also includes validation services with pre-built templates and automated document packs. The architecture is modular, allowing customers to deploy core quality modules with optional AI add-ons for enhanced compliance automation.

Differentiator

Problem solved

Functional benefit

Products and services

• Qualio Platform (eQMS) Cloud-based electronic Quality Management System (eQMS) for life sciences companies that unifies quality management, product lifecycle, and compliance intelligence in a single integrated platform. Targets medical device, pharma, biotech, cannabis, SaMD, and CRO organizations needing FDA, ISO, EMA, and GxP compliance.
• Compliance Intelligence AI-powered compliance monitoring solution providing real-time gap detection, cross-mapped evidence, and continuous monitoring across FDA, ISO, EMA, and 28+ regulatory frameworks. Built for life sciences companies needing automated gap analysis and audit readiness.
• Qualio AI Assistant Natural language interface that lets users interact with QMS content across Documents, Events, and Compliance Intelligence modules. Answers questions about procedures, drafts documents, logs events, and reviews compliance gaps using AWS Bedrock models within Qualio's AWS infrastructure.
• Qualio Validation Services Pre-built validation service providing templates and automated document packs to accelerate regulatory validation of the Qualio platform. Built around FDA and GAMP industry guidelines, enabling life sciences customers to achieve go-live two weeks faster than traditional eQMS validation approaches.

Quantifiable outcome

• 80% reduction in audit prep time
• +6 more outcomes

Named customers15 records

Segments6 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability8 records

Feature5 records

Partnerships

Six partnerships are on record, tiered minor and core.

• Platypus Medtech ConsultingminorImplementation/ SI/ Consulting PartnerQA/RA consulting firm that implements Qualio for medtech clients. Founded by Dr Lee Walsh. Uses Qualio to reduce manual administration and focus on quality management consulting.
• Anne Jury Associates LtdminorImplementation/ SI/ Consulting PartnerExternal QA/RA consultancy for medical device manufacturers. Uses Qualio as a simple, user-friendly tool to stay connected with client quality systems.
• Rallis Consulting, LLCminorImplementation/ SI/ Consulting PartnerRegulatory and quality consulting firm founded by Stephanie Rallis. Equipped with Qualio to better serve medical device clients with state-of-the-art quality management.
• Mt. Tabor Regulatory & Quality ConsultingminorImplementation/ SI/ Consulting PartnerRegulatory and quality consulting firm. Uses Qualio to focus on tasks that matter most to their customers.
• PDC Pharma StrategyminorImplementation/ SI/ Consulting PartnerCEO Penelope Przekop leads PDC Pharma Strategy. Uses Qualio as an efficient, user-friendly, cost-effective solution supporting diverse industry business models.
• AWS (Amazon Web Services)coreTechnology or IntegrationQualio runs on AWS infrastructure using AWS Bedrock with Claude and Titan AI models. Customer data processed within Qualio's AWS environment and does not leave to third-party AI providers.

Scale indicators11 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Veeva Systems: Dominant cloud platform for life sciences with Veeva Vault QualityDocs and QualityOne directly competing with Qualio's eQMS. Veeva is the entrenched leader in regulated life-sciences quality and content management, particularly among large pharma.
• MasterControl: Long-standing eQMS vendor for life sciences covering document control, training, CAPA, audits, and supplier management. Competes head-to-head with Qualio in medical-device and pharma quality management.
• Greenlight Guru: Cloud eQMS purpose-built for medical-device companies, with similar design controls, risk management, and FDA/ISO workflows. Closest SMB/mid-market competitor to Qualio's medical-device offering.
• ETQ (Hexagon): Quality management system vendor acquired by Hexagon, serving regulated industries including life sciences. Competes with Qualio on enterprise QMS, CAPA, and document control capabilities.
• ComplianceQuest: Native Salesforce-based QMS and EH&S platform with strong life-sciences vertical coverage. Competes with Qualio on document control, change management, and supplier quality for regulated manufacturers.
• AssurX: Quality and compliance management software focused on regulated industries including medical devices and pharma. Competes with Qualio across CAPA, audits, document control, and training.
• Dot Compliance: AI-enabled eQMS for life sciences built on the Salesforce platform, offering document control, training, audits, and CAPA. Direct competitor targeting pharma, medical device, and biotech customers similar to Qualio's ICP.
• Sparta Systems (Honeywell): TrackWise quality management suite for life sciences, now part of Honeywell, serving large pharma and medical-device manufacturers. Competes with Qualio in enterprise eQMS, complaint handling, and quality intelligence.
• Arena Solutions (PTC): Cloud QMS and PLM platform acquired by PTC, used by medical-device and other regulated manufacturers for design controls, document control, and supplier quality. Overlaps Qualio's design controls and supplier modules.

Broad incumbents

• ServiceNow: Broad enterprise platform with integrated GRC and risk/compliance modules that increasingly overlap with regulated compliance workflows. Represents an upstream expansion threat for eQMS specialists like Qualio at large enterprises.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/qualiohq
• Instagraminstagram.com/lifeatqualio
• Xx.com/qualiohq
• Facebookfacebook.com/qualioqms

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds7 records

Investors10 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Qualio