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21 CFR Part 820 compliance software for the Current Good Manufacturing Practice of the manufacturing and distribution of medical devices. Meet FDA regulations accurately and efficiently with the QT9™ QMS.
Keep track of medical device compliance items and synchronize documentation with anyone, anywhere.
Eliminate manual processes for medical device manufacturers.
Meet FDA regulatory requirements for your ISO & FDA compliance.
Utilize electronic signatures & integrated modules to get your QMS paperless.
Meet Current Good Manufacturing Practice (CGMP) with ease.
QT9's 21 CFR Part 820 quality management system is your all-in-one 21 CFR Part 820 software solution.
QT9™ QMS Management Review Module
QT9™ QMS Audit Management Module
QT9™ QMS Employee Training Module
QT9™ QMS Engineering Change Request Module
QT9™ QMS Document Control Module
QT9™ QMS Supplier Evaluation Module
QT9™ QMS Inspection Module
QT9™ QMS Calibration Module
QT9™ QMS Nonconforming Product Module
QT9™ QMS Corrective Actions Module
QT9™ QMS Customer Feedback Module
QT9's easy-to-use 21 CFR Part 820 system makes traceability and transparency simple.
Quickly see the status of 21 CFR Part 820 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 21 CFR Part 820 quality management system is 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 lets you choose modules based on what's best for your organization.
With multiple modules to choose from, there's solutions for nearly anyone.
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.
Speak directly to a QT9 expert.
Have questions? Want to discuss solutions?
See a personalized demo of QT9 QMS.