Stay organized with streamlined document management

Find, edit and collaborate with the world's easiest document management software.
Execute guided workflows for drafting, reviewing, approving and retiring documents.
Embed compliance with FDA CFR Part 11-compliant digital signatures.

The #1 solution to your documentation challenges



Document management and control can be time-consuming and laborious - especially with a paper-based quality system. From repetitive admin to chasing down signatures for approval, it can feel like you’re managing a daycare instead of building a real quality-centric culture.



Qualio provides an integrated digital repository for your entire documentation stack. Standardise with document templates. Save time with powerful search functionality. And embed real compliance with automated lifecycle management and compliant e-signatures. 

Streamline document creation and approval workflows

  • Create new documents from existing templates or migrate your existing stack
  • Easily find the documents you need for audits and inspections with document tags
  • Build end-to-end workflows for document approval, training and review

Have confidence your team is up-to-date

  • Ensure your team acts only on the right information with automatic version control
  • Secure your stack by assigning bespoke editing, view-only and download permissions
  • Collaborate on documents and templates in real time with other system admins 


Comply with
FDA 21 CFR Part 11

  • Meet your electronic record requirements with compliant and binding e-signatures
  • Ditch risky and insecure paper records
  • Make audits quick and painless with out-of-the-box document compliance


Secure complete control

  • Meet ALCOA+ principles with complete document lifecycle control
  • Trace all document activity with incorruptible audit trails
  • Export documents and reports with a click and demonstrate compliance to your auditors and interested parties


Have quality and regulatory
experts on your side

Add Qualio+ to your plan and receive expert quality assurance
support to help your business scale, mature and get to market.

Ready-to-go regulatory content

Access pre-configured templates and documentation for faster and smoother FDA & ISO compliance.


Quality assurance

Work with our team of seasoned quality experts to ensure you meet - and exceed - your QA goals.

Don't just take our word for it!

“You can look at an SOP in Qualio, see the list of associated documents, and click hyperlinks to retrieve information immediately. That’s one feature I’m greatly enjoying.”
Tyler Cochran
Executive Director of Quality, Linical Americas
“Qualio has helped make my life as a Quality Manager very easy. For the documentation side, as soon as an auditor comes in and audits, they can see everything in the audit trail. Nothing is missing, nothing can be changed without it being documented and the auditors think that is so great.”
Gene Vought
Quality, Cirris
“Having everything in one place. That you can connect or link documents to other documents and keep the traceability of any changes made or decisions made.”
Dragan Velickovski
Software Engineer, Axiom
“Qualio has made it so much easier to review and edit documents prior to document release. This has improved the quality of our documentation and reduced the amount of time spent on getting documents through our release process.”
User in Medical Devices
”I like the very flexible approach that Qualio offers to deal with document type of information. A document can be basically everything from an SOP, over an HR file to an Equipment log. This is very powerful in particular in combination with the tagging feature.“
Christian S
Consultant CMC + QA
“The best thing I like about Qualio is how simple the documents are prepared for easy understanding by anyone who has no knowledge on what they're reading, be it a policy or a basic learning document.”
Sravya D
Medical Fulfillment Specialist

See other features that make Qualio
the #1 top rated cloud QMS


Design controls

Supercharge your product development from a single source of truth.


Risk management

Master your risk environment, detect and mitigate risks and comply with ISO 14971.


Training management

Build a competent, confident, compliant, continuously improving workforce.


Change control

Manage change activity easily and effectively with complete traceability.


Audit management

Make compliance and audit readiness the natural core of your business DNA.


CAPAs & Nonconformances

Build automated response workflows for any quality event.


Learn why we're ranked the quality management platform of choice