Simplify Quality Management

Qualio is simple & intuitive, so managing SOPs, controlled documents & training isn’t intimidating.

Simplify Quality Management

More Effective Than A List

In the dashboard view, you can see all your actions and draft content. This clearly shows you what you need to do and helps you focus on the right actions at the right time.

See All Your Actions

See the actions you have by context, such as documents needing review, approval or training. Always up to date and perfect for quickly getting to the heart of your task list.

Quickly Access Content

Find the content you are working on instantly. All you need to do is select the edit button and you are ready to go. No more looking inside folders within folders.

Dr. Christopher Devine
“As consultants we have the pleasure of working with the good, the bad, and at times, the ugly, when it comes to Quality Management software. Qualio simplifies the approach to effective document control management. The web-based software is intuitive, which greatly reduces the amount of time required for users to come up to speed with a new platform.”
Dr. Christopher Devine
President and CEO, Devine Guidance International

Create controlled documents and records

Creating policies, procedures and other controlled content has never been so easy.

Create controlled documents and records

Integrated document change control

Set workflows for review, approval

Assign trainees

QMS Documents (policies, SOPs, work instructions, forms & related content)

Other controlled documents in any format

Web based document editor

Document templates

Automated document numbering

Create smart links between documents

Add attachments

Get Feedback

Everyone can take part in the review process, even if off-site or travelling. Users can review and comment on documents in parallel, reducing bottlenecks and improving the quality of feedback.

Get Feedback

Automated email notifications sent to reviewers

Real-time parallel review process

All reviewers see the same document

Compare against previous document versions

Respond & resolve comments

Mark as reviewed to notify author

Capture Approvals

Approvers can approve documents from anywhere.

Capture Approvals

Automated email notifications sent to approvers

Real-time parallel approval process

Digital signatures

FDA 21 CFR part 11 compliant

Manage Training

Training is seamlessly integrated with document workflows.

Manage Training

Automated training notifications sent via email.

Read & understand signature captured

Email reminders

Training list can be edited at any time

Create training assessments with ease


Create training assessments with ease

Create unlimited number of multiple choice questions

Must be completed by every trainee

Easy to create assessments to prove training competency

Built into document control workflow

Track Compliance

Reduce your risk of non-compliance with powerful reporting tools.

Track Compliance

See what’s happening in real-time with up-to-the-second reports.

Get detailed insights into documents, people and their actions.

See which content is waiting on review, approval or training to completed.

View completed and in progress change controls.

Review every event in the comprehensive audit trail.

Unlimited Support

Have a question? Get in touch. All users get unlimited free email and phone support.


  • Search the FAQ

    1. Search the FAQ

  • Send an email

    2. Send an email

  • Call us for help

    3. Call us for help

Easy To Implement

Qualio runs in the cloud and can be setup in record time.

Training, setup and on-boarding provided at no extra charge to all customers.

Validation information & support provided to Life Sciences organizations to ensure they can easily validate Qualio. Qualio is GAMP® 5 category 3 software and validation takes less than one day.

Account setup and configuration by Qualio support to ensure you are setup for success.

Full knowledge base to enable users explore software at their own pace.

Regular webinars to ensure everyone has an opportunity to learn how to get the most from Qualio.

Customize Everything

Set-up Qualio to be just the way you want it.

Customize Everything

Create your own document templates

Create your own change control template

Specify document numbers

Decide who can view documents or approve them

Full Standards Compliance

Qualio is compatible with all regulatory directives and compliance standards.

Perfect for these industries


Healthcare, Life Sciences, Manufacturing, Oil & Gas, Aerospace, Education, Finance, Public Sector, Retail, Services.

Compatible standards & regulations

  • Quality management systems (ISO 9001)
  • Medical Devices (ISO 13485)
  • Environmental Management (ISO 14001)
  • Food safety (ISO 22000)
  • HACCP (ISO 22001)
  • Information security (ISO 27001)
  • Occupational health & safety (OSHAS 18001)
  • FDA Quality Systems Regulations (QSR)
  • e-record keeping (FDA 21 CFR p11, Annex 11)
  • Corporate Governance (Sarbanes-Oxley) (SOX)
  • and more…

Reliable  & Secure

Best-in-class hosting infrastructure, multiple daily off-site backups. Trusted all around the world.Padlock

Your data is in good hands

Your data is yours only and we aim to keep it this way. We’ve gone into painstaking detail to ensure maximum uptime and safety of your records. We employ secure connections, where information is encrypted.

We do backups, and backups of backups

All data is backed up in real time to a separate server that we can switch to in case the main one has a problem. We then do multiple daily offsite backups of the entire database.

Simple Import & Export

We’ve made it very easy to import your existing data to Qualio, or export it.

Simple Import & Export

Simple to get started

You can import your system in no time at all, and our support team will help ensure you are setup for success.

Export your data whenever you need

You can download your customer data at any time, and you can also use our API to download all or some of it.