Centralize your quality management processes.

Easily manage 21 CFR Part 211 compliance items with anyone, anywhere.

Automate workflow

QT9 QMS reduces staff time by eliminating manual processes.

Ensure FDA compliance

Meet FDA regulatory requirements for pharmaceuticals.

Connect & collaborate

Centrally upload, publish & distribute documents.

Meet CGMP regulations

Meet Current Good Manufacturing Practice (CGMP) with ease.

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See how QT9™ QMS stacks up against FDA 21 CFR Part 211 compliance.

The QT9 QMS is your all-in-one FDA 21 CFR Part 211 software solution.

Management Responsibility

QT9™ QMS Management Review Module

Subpart B 211.100

Quality Audit

QT9™ QMS Audit Management Module

Subpart B 211.22


QT9™ QMS Employee Training Module

Subpart B 211.25

Design Controls

QT9™ QMS Engineering Change Request Module

Subpart A 211.100

Document Controls

QT9™ QMS Document Control Module

Subpart D 211.22

Purchasing Controls

QT9™ QMS Supplier Evaluation Module

Subpart B 211.84

Production & Process Controls

QT9™ QMS Inspection Module

Subpart B 211.110

Measuring & Testing

QT9™ QMS Calibration Module

Subpart B 211.192

Nonconforming Products

QT9™ QMS Nonconforming Product Module

Subpart B 211.192

Corrective & Preventive Actions

QT9™ QMS Corrective Actions Module

Subpart A 211.22

Customer Complaint Files

QT9™ QMS Customer Feedback Module

Subpart B 211.192


QT9™ QMS Risk Assessment Module

Subpart B 211.192

Track all your 21 CFR Part 211 information in one place.

QT9's easy-to-use 21 CFR 211 system makes pharmaceutical traceability and transparency simple.

Built-In Dashboard

Quickly see the status of 21 CFR 211 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 21 CFR Part 211 quality management system is 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.

Modules for any business size

With multiple modules to choose from, there's solutions for nearly anyone.

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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