Qualio
by Qualio · Healthcare & Life Sciences
AI-powered eQMS for life sciences: document control, CAPA, training, audits and compliance.
Updated August 2026 · By the ERP Research Editorial Team · Independent and vendor-neutral.
- Deployment
- Cloud
- Company size
- SMB, Mid-market
- Pricing
- Annual subscription, quote-based
- Founded
- 2012
- Headquarters
- San Francisco, California, United States
Overview
Qualio is a cloud-based electronic quality management system (eQMS) built for life sciences companies -- medical device, pharmaceutical, biotech, software-as-a-medical-device (SaMD), CRO and cosmetics organizations -- to manage the quality processes required for FDA and ISO compliance. Founded in 2012 and headquartered in San Francisco, Qualio reports serving 700+ customers across 80+ countries.
The platform covers document control, design controls, risk management, training management, change control, audit management, CAPA, non-conformance tracking and supplier management from a single system, with analytics dashboards for documents, training, events and suppliers. Qualio markets a "Compliance Intelligence" capability that uses AI to flag compliance gaps against more than two dozen regulatory frameworks, including ISO 13485, ISO 9001, FDA 21 CFR Part 11, MDSAP and EU CE/UKCA marking requirements.
Qualio's documented integrations focus on business tools -- Salesforce, Google Workspace, Microsoft 365, Jira, GitHub, GitLab and Zendesk among them -- rather than ERP systems specifically, and it offers a public API for custom connections. It is sold on an annual subscription across Foundation, Growth and Scale plans, plus an implementation fee; no list prices are published.
Screenshots & demo
Demo video from the vendor's YouTube channel. Screenshots sourced from Qualio.
Modules & capabilities
Qualio covers 18 of 54 capabilities we track in this category (+1 partial)
33%- Document version control & approval workflowsVersion control and approval workflows, automatic revision trackingCore strength
- Electronic signaturesSupported
- Training linked to document changesTraining plan assignment linked to document changesCore strength
- Training records & competency trackingTraining records and compliance trackingSupported
- SOP authoring & controlControlled document templatesSupported
- Collaborative document authoringNot evidenced
- Role-based document access controlSupported
“Not evidenced” means our research found no public documentation of this capability — the vendor may still offer it. Confirm on a demo.
Common use cases
- Managing document control and version approval ahead of an ISO 13485 audit
- Tracking CAPAs and non-conformances end-to-end with root-cause analysis and effectiveness checks
- Running supplier qualification and ongoing supplier quality oversight
- Assigning and tracking employee training tied to controlled document updates
- Using AI-driven Compliance Intelligence to identify gaps against ISO, FDA and EU regulatory frameworks before an audit
- Consolidating quality records for a CRO or SaMD company operating across multiple regulatory jurisdictions
- Preparing for FDA 510(k) submissions or ISO 13485 certification with a single quality system of record
Strengths & considerations
Strengths
- Compliance Intelligence AI feature maps quality records against 28+ regulatory frameworks to surface gaps automatically
- Purpose-built for life sciences (medical device, pharma, biotech, SaMD, cosmetics) rather than a general-purpose QMS
- Qualio itself is ISO 9001 and ISO 27001 certified, not just its software's compliance-tracking features
- Serves 700+ customers across 80+ countries with a G2 rating of 4.7/5 (667 reviews)
Used Qualio with your ERP? Rate it in 30 seconds — it helps every buyer after you.
Rate itPricing
Full Qualio pricing breakdown — cost at 25/100/500 seats, competitor rates & FAQs
Qualio does not publish pricing. Third-party sources estimate its Foundation tier around €25,000 a year, though this is not vendor-confirmed and should be treated as directional. It is a cloud eQMS aimed at life-sciences and medical-device companies that need FDA and ISO 13485 compliance without an enterprise implementation, positioning it against Greenlight Guru at a broadly comparable entry point but with a wider life-sciences remit. Get an independent shortlist with pricing guidance below.
What does Qualio cost?
Qualio prices by quote, like most of this category. Here is what actually drives your number — and what to ask before you get one.
9 of the 12 vendors we track in this category publish no list price at all.
Technical & security
- Hosting
- SaaS (multi-tenant)
- Compliance
- ISO 13485, ISO 9001, 21 CFR Part 11, MDSAP, ISO 27001
About the vendor
- Founded
- 2012
- Headquarters
- San Francisco, California, United States
- Employees
- ~120
- Ownership
- Private (venture-backed, Series B)
Alternatives to Qualio in Healthcare & Life Sciences
Qualio — frequently asked questions
What regulatory frameworks does Qualio support?
Qualio's Compliance Intelligence maps quality records against more than 28 regulatory frameworks, including ISO 13485, ISO 9001, FDA 21 CFR Part 11, MDSAP and EU CE/UKCA marking requirements.
What industries use Qualio?
Qualio is built for life sciences companies -- medical device, pharmaceutical, biotech, SaMD, CRO and cosmetics organizations -- with 700+ customers across 80+ countries.
Does Qualio integrate with ERP systems like NetSuite or QuickBooks?
Qualio's documented integrations focus on business tools such as Salesforce, Google Workspace, Microsoft 365, Jira, GitHub and Zendesk rather than ERP systems; ERP connections would need to go through Qualio's public API.
How is Qualio priced?
Qualio sells three annual subscription tiers -- Foundation, Growth and Scale -- priced by number of editing users, compliance frameworks and integrations included, plus an implementation fee. It does not publish list prices.
Is Qualio itself certified to any standards?
Yes, Qualio holds ISO 9001 and ISO 27001 certification as a company.
Compare Qualio head-to-head
The Healthcare & Life Sciences Buyer's Guide
Before you commit to Qualio, see how it sits against the 12 healthcare & life sciences systems we track — on capability, ERP integration depth and what each one actually charges for.
Healthcare & Life Sciences Buyer's Guide
12 systems compared · 2026
ERP Research
- Qualio compared side-by-side with 11 alternatives
- ERP integration checklist — what to verify before you shortlist
- The pricing questions that change the quote
- A Qualio evaluation brief, included with the guide
Healthcare & Life Sciences Buyer's Guide
Get a quote for Qualio
Qualio publishes a list price, but the number you pay depends on volume, modules and integration scope. Tell us your setup and we'll come back with a realistic figure and the alternatives worth quoting against it.