Pricing - get a quote for your new eQMS today

One platform, three plans.

Pick the one that matches where your compliance operation is today. You move up when the job changes, and you never re-buy the platform.

Foundation.Get audit-ready.

For companies formalizing quality for the first time.

Launch a complete, trusted QMS from day one
Find your gaps before the auditor does
Walk into your first audit ready

Start for free

Growth.Stay continuously compliant.

For companies where compliance is a year-round operation.

Move from audit-prep cycles to continuous readiness
Carry more frameworks without more headcount
Connect the systems your teams already work in

Start for free

Scale.Govern compliance at scale.

For mature organizations whose compliance estate is itself complex.

One governed view across entities, sites, and systems
Deeper validation and security for demanding reviews
Custom-scoped with our team

Talk to sales

What is included

AI agents & Copilot - included in every plan

Find your gaps before the auditor does

Your documents mapped to every control

Guidance to close every gap you find

Evidence collected as the work happens

Qualio Copilot: ask your quality system anything

Quality Management

Document control, training, supplier quality, quality events

Quality event templates

Up to 10

Unlimited

Resource library, reporting & analytics

Regulated Product Lifecycle

Design controls

Dev-tool integrations (GitHub, GitLab, Azure DevOps, and more)

Compliance Frameworks

Compliance domains included

Additional domains

Add-on

Custom framework builder

Compliance dashboard, audit collaboration

Platform foundation

Trust layer: approvals, audit trails, provenance, validation packs

always included, never metered

Core integrations (SSO, OneDrive/SharePoint, Jira)

Integration Hub

Developer API

MCP: drive Qualio from your own AI tools

Sites / instances

Single

Single (add-on available)

Multi-site

People

Basic users: read and train

Unlimited

Edit users included

10+

A flat annual platform fee. Four things move the number

Annual contracts. Plans start at $25,000 per year.

1. Your plan

2. Compliance domains you carry

3. Sites and connected systems

Licensed users

Everyone else in your company reads and trains free.

What customers stop paying for

Customers measure the return in consultants not paid, headcount not added, and audit prep weeks reclaimed. And because basic users are unlimited, the whole company works in the quality system without a seat bill.

Sentec

eliminated $150-300K per year in consultant spend.

NeuFit

saved $130K in planned headcount and consultancy.

eClinical Solutions

mitigated 3-4 FTE salaries.

“Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE.”

Mike TrudnakVP of IT & Information Security, xCures

Case study

Trusted by 700+ life sciences companies, from first certification to Fortune 100.

4.7/5 on #1 Most Implementable eQMSCapterra 4.6/5

Frequently asked questions

How is Qualio priced?

An annual platform subscription with three plans. The fee is flat per plan and grows with your compliance surface: the domains you carry, the sites you run, the systems you connect, and the licensed users who author, review, and approve records. It is never priced per basic user, per message, or per AI action. There is no usage metering: the AI does more work for you without the bill moving.

Is the AI extra?

No. Approvals, audit trails, provenance, and validation packs are part of the platform fee and are never metered.

Which plan is right for us?

Formalizing quality for the first time, with an audit or certification coming: Foundation. Compliance as a year-round operation across multiple frameworks, with more systems to connect: Growth. A mature, complex compliance estate, whether that is multiple entities and sites, deep validation and security demands, or executive-level governance needs: Scale.

How do seats work?

Everyone in your company can read and train at no cost, in every plan. The people who author, review, and approve records are licensed users; plans include a set of them, and more are a priced add-on.

Can we add domains, sites, systems, or users mid-term?

Yes. That is the designed expansion path, and it follows the same shape as your company's growth. New market, new framework: add a compliance domain, with included coverage first (Foundation includes 3 domains, Growth includes 5), then a per-domain add-on. New site or entity: add an instance; when governance itself becomes the job, that is the Scale conversation. More connected systems: core integrations (SSO, OneDrive/SharePoint, Jira) come with every plan, and the full Integration Hub, developer API, and MCP access come with Growth and above. A bigger quality team: add licensed users, while company-wide read and train access stays unlimited and free at every plan. Adding surface never re-opens the whole contract, and you never re-buy the platform to grow.

What does implementation involve?

Guided implementation with document migration included, scoped by plan. Deployments typically go live in under 60 days; 30 Technology went from first contact to live in under two months.

Is the system validated for GxP environments?

A validation pack ships with every major release, so you can adopt new releases without a parallel validation project.

Which standards does Qualio cover?

ISO 13485, FDA QMSR, EU MDR, MDSAP, GxP, 21 CFR Part 11, ISO 42001, and more.

Full list

What is the typical contract?

Annual, with multi-year options.

How does security review work?

SOC 2 and ISO 27001 documentation, DPA, and security questionnaire support are standard in procurement.

Get a number you can take to procurement

Tell us which frameworks you carry and how your organization is structured. We'll come back with a real quote.

Priced to your compliance surface.