Pass every audit every time with the #1 audit management software

Don’t leave your audit preparation to chance. Easily comply with the wide range of quality standards with Qualio’s cloud-based and fully integrated quality management system.



Audits can be large and resource-heavy activities due to the scope of examining the entire quality system periodically. 

Quality managers can feel tremendous stress if there are gaps in their data and quality processes. Being unprepared for an audit, whether internal or external, can lead to fines, penalties, or worse product recalls. 


Qualio’s cloud-based quality management system gives your team the tools to be 100% audit-ready at any time. 

Easily provide all artifacts needed for an audit, prove compliance, demonstrate continuous improvement, and report on the status of any findings. 

With Qualio, audits are faster and no longer stressful. 

Be 100% compliant and inspection ready.

  • Show continuous improvement from past audits with organized documents, procedures, and automated internal audit schedules and tasks. 
  • Identify gaps and predict quality performance with a connected quality ecosystem. 
  • Have confidence knowing your system is fully compliant with ISO 9001, ISO 13485, ISO 14971, FDA CFR Part 11, CFR 820, CFR 210/211, and EU MDR to name a few.


Save time with automated document and data processes

  • Avoid the challenges of paper-based audits with a cloud-based QMS complete with controlled access—making even remote audits possible. 
  • Find all audit artifacts with one click using document templates and tagging.
  • Build workflows to assign tasks and automate reminders all from one place.

Make audit-readiness your competitive advantage

  • Turn fines, penalties, and product recalls into a thing of the past by connecting your data and teams into one centralized quality system.
  • Easily assign audit tasks, manage due dates, and track any audit findings to completion. 
  • Enjoy end-to-end traceability for all CAPAs, nonconformances, and other quality events to show auditors continuous improvement.


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.

“My favorite thing is how Qualio keeps us in a constant state of audit readiness. We chose Qualio as we needed our system to be scalable to support our rapid growth and facilitate quick employee onboarding.”

Deb Glancy
Director of Quality Ultragenyx

“The changelog in Qualio has been particularly helpful. We can print it out and give it to the auditor to show we’re still compliant since we validated two years ago, for example.”

Adolfo Ramirez
Director of Information Systems and Data Compliance

“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

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

Document Management

Training Management

Design Control

Risk Management

CAPAs & Nonconformances

Change Control

Join a Live Qualio Demonstration