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.

Automate compliance

Eliminate manual processes for medical device manufacturers.

Ensure FDA compliance

Meet food and drug administration requirements

FDA QSR made paperless

Utilize electronic signatures & integrated modules to get your QMS paperless.

Meet CGMP requirements

Meet Current Good Manufacturing Practice (CGMP) with ease.

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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.

Management Responsibility

QT9™ QMS Management Review Module

Subpart B 820.20

Quality Audit

QT9™ QMS Audit Management Module

Subpart B 820.22


QT9™ QMS Employee Training Module

Subpart B 820.25

Design Controls

QT9™ QMS Engineering Change Request Module

Subpart C 820.30

Document Controls

QT9™ QMS Document Control Module

Subpart D 820.40

Purchasing Controls

QT9™ QMS Supplier Evaluation Module

Subpart E 820.50

Production & Process Controls

QT9™ QMS Inspection Module

Subpart G 820.70

Measuring & Testing

QT9™ QMS Calibration Module

Subpart G 820.72

Nonconforming Products

QT9™ QMS Nonconforming Product Module

Subpart I 820.90

Corrective & Preventive Actions

QT9™ QMS Corrective Actions Module

Subpart J 820.100


QT9™ QMS Inspection Module

Subpart G 820.72

Customer Complaint Files

QT9™ QMS Customer Feedback Module

Subpart M 820.198

Track all your FDA compliance in one place.

QT9's easy-to-use platform makes traceability and transparency simple.

Built-In Dashboards

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.

Electronic Signatures

Make approvals electronically with electronic signature capturing built-in. QT9's user-friendly quality management system is FDA 21 CFR Part 11 compliant.

Software Validation

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.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

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Talk to a Specialist

Speak directly to a QT9 expert.


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Have questions? Want to discuss solutions?

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See a personalized demo of QT9 QMS.

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