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.

Standardize with document templates.
Save time with powerful search functionality.
And embed real compliance with automated lifecycle management and compliant

Streamline document creation and approval workflows

  • Make new documents with standardized templates and upload files in any format
  • 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
  • Integrate with OneDrive to embed document compliance even as your colleagues work in other systems


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


Document management resources


The case for document management

Read our whitepaper to learn the 6 key reasons your life science business should embrace an electronic document management system.

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Document management datasheet

Access our datasheet to dive into the core functionality of Qualio's Documents area and the operational benefits you can expect.

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


Design control management

Supercharge your product development from a single source of truth.


Risk management

Detect and mitigate risks and comply with
ISO 14971 and ICH Q9.


Training management

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


Change control management

Manage change activity easily and effectively with complete traceability. 


Audit management

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


CAPA & NCR management

Build automated response workflows for any quality event.


Supplier management

Control and categorize suppliers and third parties with complete visibility.

Don't just take our word for it!

Hear from our many happy customers

“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 C.
Executive Director of Quality, Linical Americas
“For documents, as soon as an auditor comes in 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 V.
Quality Manager, Cirris
“Qualio gives me everything in one place. You can connect or link documents to other documents and keep the traceability of any changes made or decisions made.”
Dragan V.
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.”
Medical Device SME
”I like the very flexible approach that Qualio offers to deal with documented types of information. A document can be basically everything from an SOP to an HR file or equipment log. This is very powerful, particularly in combination with the tagging feature.“
Christian S.
CMC/QA Consultant
“The thing I like best about Qualio is how simple the documents are prepared for easy understanding by anyone who has no previous knowledge of what they're reading, be it a policy or a basic learning document.”
Sravya D.
Medical Fulfillment Specialist

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