Stay organized with streamlined document management

Find, edit, and collaborate with today's easiest document management software. Execute guided workflows for drafting, reviewing, approving, and retiring documents. Save time with FDA CFR Part 11 compliant digital signatures.


The #1 Solution that Solves Today's Challenges


Document management and document control can be time consuming and laborious, especially with a paper-based quality system. 

From repetitive tasks to chasing down signatures for approval, it can feel like you’re managing a daycare instead of building a quality system and culture.


Qualio streamlines document management with a powerful web editor to digitize and store all your documents online. Using document templates, library-wide search, and tags to be more organized than ever before. 

With compliant e-signatures and approval workflows, you can stop worrying about repetitive tasks and focus on real quality.


Streamline document creation and approval workflows

  • Create new documents from existing templates or upload your existing SOPs.
  • Easily find the documents required for audits and inspections with document tags. 
  • Build workflows for document approval, training, and review period.

Have confidence that your team is up-to-date

  • Document version history keeps your team working on the most recent version.
  • Ensure documents are secured by assigning editing, view-only, and download permissions.
  • Collaborate on documents and templates in real-time with other admins on your team.

Comply with CFR Part 11 digital signatures

  • Reduce risk and simplify compliance with easy and binding e-signatures.
  • Show all signatures in one system, removing the need to store original paper copies.
  • Make audits easier and faster with out-of-the-box compliance.

Secure sharing, access and change audit log

  • Define access control so only certain people can see your documents.
  • Trace document changes as quality procedures get updated. 
  • Export documents with one-click and send the auditor or quality consultant.

Have quality and regulatory experts on your side

  • Save time and resources by utilizing our expert quality team.
  • Get up and running quickly and through validation in record time.
  • End-to-end concierge service from SOPs, gap assessments, to internal/supplier audits and more.

Learn more about Qualio Plus >>

Don’t take just 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

I have everything I need as documents are concerned at one place. I really, really appreciate not having to deal with paper. Now everything is done through Qualio and the quizzes and signatures are handled via the interface. Documents are nicely contained via your personalized dashboard. You got to like the notification system around the introduction and due dates around the documents.

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
Small-Business(50 or fewer emp.)

You can get any document you need very quickly and present it within a matter of minutes, compared to other systems that require long, drawn-out processes that are not necessarily as quick or friendly.

Tyler Cochran
Executive Director of Quality, Linical Americas

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, Quality
Consultant CMC + QA

See other features that make Qualio the #1 Top Rated Cloud QMS.

Training Management

Design Control

Risk Management

Change Control

CAPAs & Nonconformances

Audit Management

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