#1 Rated CAPA management software in the US used to streamline compliance, fast.

Qualio automates the painful paperwork and processes through CAPA's and NCMRs. The platform connects all quality processes for 2x faster accreditation and approval while being 5x faster than paper or traditional solutions to achieve 100% FDA/ISO/GxP compliance in audits.

Breeze Through Compliance with Qualio Today

Your modern QMS is waiting

More success and less stress with everything centralized in one off-the-shelf QMS.

Schedule A Free Demo

Experience the modern QMS platform that maintains 100% compliance and audit readiness, always.

Get a personalized demo to see why hundreds of Medical Device, Pharma, and Biotech companies trust Qualio’s solution to bring their team, tools, and data together in one place.

We'll convert your manual, paper-based system to our easy-to-use platform for free. Easily nail FDA, ISO, and GxP compliance and become quality-driven today with Qualio.

100% audit-readiness is at your fingertips

Audit Management
Equipment Management
Complaint Management
ISO Standards Management
Compliance Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Document Management

Qualio’s eQMS unites your teams, processes, and data, so you can get your products to market quickly and scale successfully.

Edit and collaborate on documents with Qualio’s simple web editor
Execute guided workflows for drafting, reviewing, and approving documents
Incorporate FDA CFR Part 11 compliant digital signatures
Retire documents
Create a template library as the basis for your documents

Mitigate risk, detect nonconformities, and scale with ease

Streamline Product Development
Bring devices to market quickly with design control and risk management features that integrate with your pre-production and post-production quality activities.

Identify and Resolve Issues
Quickly capture quality events like non-conformances, deviations, customer complaints, and much more.

Assign and Capture Training
Training assessments make it possible to go beyond "read and understand" training to capture competency.

Pass Audits and Drive Growth
Qualio provides a single place to manage audits, suppliers, and change management. Understand what's happening across your entire business in real-time.

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5-star reviews on Capterra, G2, Getapp, and SoftwareAdvice

Consistently ranked as the quality management platform of choice by medical device
manufacturers, therapeutics companies regulated contract service providers.

I find Qualio a brilliant software.

Pamela

Director of Clinical Development

All requires aspects of a QMS are present in Qualio.

Drew

Director of Quality

It is very user friendly and intuitive.

Paul

Med Device Account Manager

Exceptionally great, easy to access SOPs.

Elias

Medical Technologist

Easy to locate and review documents.

Mallory

Clinical Trial Associate