Free Validation Report Included.

QT9 QMS's free validation report makes it easy for medical device manufacturers to conduct audits.

FDA Part 820 Compliance

Designed for medical device manufacturers.

FDA 21 CFR Part 11 Compliance

Easily capture electronic signature approvals.

Lot & Serial Traceability

Control inventory & set expiring inventory alerts.

QMS Integration

Integrate Inspection Plans, Inspection Records, & QMS documents.

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Electronic Device History Records (eDHR)

One-click electronic Device Master Records (eDMR) and electronic Device History Record (eDHR) capability.

Device Master Record

Utilizing your QT9 ERP Bill of Materials, QT9 QMS documents, QT9 QMS inspection plans, and file attachments, QT9 ERP Web can deliver a “one click” eDMR at your fingertips. No paper needed. No separate folder structures. eDMRs are tied to any revision of your manufactured item’s Bill of Materials.

Device History Record

Print off your Device History Records from your completed and approved jobs. eDHRs in QT9 ERP Web can be multi-level, utilize QT9 QMS inspection records, labels, job file attachments, and custom job print outs. No paper or manual compilation of Device History Records is needed in QT9 ERP Web!

Compliance Portal

The QT9 ERP Web compliance portal is a separate web portal for users to guide FDA auditors to DHR and DMR records with printout capabilities without exposing auditors to the main ERP Web interface. The compliance portal also has the ability to allow approvals on jobs to push completed inventory into an available status.

Real-time Device History Records.

Sign in online anytime, anywhere to get a real-time view of your device history records.

Built-In Dashboard

Quickly view the status of device history records from the QT9 dashboard and easily personalize the view.

Never Miss a Deadline

Prevent action items from falling through the cracks with automated email alerts and reminders.

Traceability & Transparency

QT9™ QMS includes web portals for customers, suppliers and employee training.

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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Live Demo Request

See a personalized demo of QT9 QMS.

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