FDA 21 CFR Part 820 compliance for the modern medical device manufacturer.
Keep track of medical device compliance items and synchronize documentation with anyone, anywhere.
See how QT9™ QMS stacks up against 21 CFR Part 820 compliance.
QT9's 21 CFR 820 quality management system is your all-in-one quality management software solution.
Track all your FDA compliance in one place.
QT9's easy-to-use platform makes traceability and transparency simple.
Quickly see the status of FDA compliance items with real-time reports from the QT9 dashboard. You can even personalize the view specific to your needs.
Make approvals electronically with electronic signature capturing built-in. QT9's user-friendly quality management system is FDA 21 CFR Part 11 compliant.
QT9 QMS is validated after each release, and it is in line with FDA QSRs to keep you in compliance with FDA quality system requirements.
QT9™ QMS is flexible for your business.
QT9 lets you choose modules based on what's best for your organization.
Connect multiple operations
Establish and maintain procedures across locations, departments and people.
A solution that scales with you
Whether you are a large corporation or a small start-up you can use as many modules as you want.
Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.