Multi-site complianceEvery site audit-ready,
Every site audit-ready,
whatever system it runs on
Run Qualio as the quality system at the sites that need one. Where a site keeps the QMS it already runs, Qualio's compliance agent reads it alongside the site's other systems. Every site is assessed against the same frameworks, and no site has to migrate to be included.
4.7/5 on (667 reviews)
WHAT ACQUISITIONS LEAVE BEHIND
Every acquisition adds a site, and often another QMS
Few groups chose to run three quality systems. They bought them. Each site keeps its own procedures, records and audit calendar, and corporate quality learns how a site is doing when its auditor does.
Several QMSs, none leaving soon
Moving every site onto one system takes years, and the next acquisition restarts the clock.
No view across sites
Leadership asks how the group stands against ISO 13485. The answer is a spreadsheet stitched together from site reports.
One standard, rewritten at every site
Each site writes its own SOPs to the same clauses, and corporate templates drift once they land.
THE STAKES
The next acquisition arrives before the last one is harmonized
SITE BY SITE
Bring each site in the way that suits it
Some sites need a quality system. Others have one that works and an audit coming. Qualio runs as the QMS at the first kind and as a compliance agent on top of the second.
Both are assessed against the same frameworks, so corporate quality compares every site on the same clauses.
THREE WAYS IN
Consolidate, phase or layer on top
You can mix all three across your sites. The right path for each depends on its system, its audit calendar and the budget.
Standardize on Qualio
Move a site's documents, training, quality events and suppliers onto Qualio. Each site or entity gets its own instance, with easy navigation between them.
Replace the weakest system first
Move the site you most want off its current system onto Qualio, and connect the rest. Bring more sites across as budgets and audit calendars allow.
Keep the QMS a site already runs
Qualio's compliance agent reads the site's documents read-only and assesses them against your frameworks. Veeva Vault and MasterControl connect today in early access.
One set of frameworks
Hold every site to the same clauses
Jira
Veeva
OneDrive
Confluence
Azure DevOps
GitHub
Zendesk
MasterControl
Salesforce
Intercom“The auditors said it was very rare that we passed our ISO 13485 audit without any comments. I think Qualio helped a lot in that process.”
WHERE EACH PIECE STANDS
What runs today, and what is in early access
We are building the multi-site layer with the groups that run it. Here is where each part stands.
An instance per site or entity
Each site runs its own Qualio instance, with its own users, workflows and validation.
The same frameworks at every site
Every instance assesses its records clause by clause against the frameworks you choose, with the evidence behind each finding.
Read-only connections to the tools sites use
Jira, GitHub, Zendesk, SharePoint and more feed the assessment, and nothing is written back to them.
Parent accounts and shared templates
Corporate quality publishes SOP and quality manual templates from a parent account, and each site adopts them with local changes.
The agent on top of Veeva Vault and MasterControl
Sites that keep their QMS are assessed read-only against the same frameworks as the rest.
One view across sites
Open gaps, CAPAs and readiness by site and framework in one place, built with our early access customers.
Ready for enterprise review
Validated for GxP
A validation pack ships with every major release, so each site adopts it without a parallel validation project.
Read-only to the systems you keep
The agent reads from the QMS and tools a site keeps. It writes nothing back to them.
Your approval on every AI output
Every draft and recommendation waits for sign-off at that site, and the audit trail records who approved it.
Documentation for procurement
ISO 27001 documentation, a data processing agreement and security questionnaire support come as standard.
Frequently Asked Questions
Do all our sites have to move to Qualio?
No. A site can run Qualio as its QMS, or keep the QMS it has and run the compliance agent on top. You can do some of each, and move sites across as budgets and audit calendars allow.
How is each site set up?
Each site or entity gets its own Qualio instance, with its own users, workflows and validation. A smaller group can also run several entities in one instance, separated by tags, as Distica does for six sister companies.
Can corporate quality push procedures down to sites?
Yes, in early access. A parent account publishes SOP and quality manual templates, and each site adopts them into its own instance with local changes where it needs them.
Which QMSs can the agent work on top of?
Veeva Vault and MasterControl connect directly, in early access. Documents from other systems can come in through SharePoint, the developer API or upload. See the integrations directory.
Will new releases affect our validated sites?
A validation pack ships with every major release, so each site can adopt it without a parallel validation project.
Where is our data hosted?
In AWS, in the EU (Ireland). If a site needs another region, raise it early in the conversation.
Does Qualio train AI models on our data?
No. The AI works on the records you connect, inside Qualio's infrastructure. Every output cites its source and waits for your approval.
How is multi-site priced?
Each site or entity is an instance on your plan, and the Scale plan covers multiple sites and entities. Adding a site never reopens the whole contract. See plans.
How many sites, and how many systems?
Bring your site list and the system each one runs. We will map which sites to consolidate, which to phase and which to layer on top.
667 reviews4.7/5