Electronic Device History Records (eDHR) made easy.
Generate single-level and multi-level electronic Design History Records (eDHR) and electronic Device Master Records (eDMR) and for the medical device industry in one-click with QT9.
Automate Electronic Device History Records
QT9™ Solutions are automating processes for medical device manufacturers.
FDA 21 CFR Part 11 Compliance
Easily capture electronic signature approvals.
Lot & Serial Traceability
Control inventory & set expiring inventory alerts.
FDA Part 820.181 Device Master Record Compliance
QT9 Software is your one-stop medical device manufacturing solution. With the power of QT9 ERP™ and QT9™ QMS, you can completely automate your device master records utilizing QT9™ ERP’s Bill of Materials combined with QT9™ QMS modules. This gives you the ability to create any device master records at the click of a button.
Device Specifications
QT9 ERP Bill of Materials / QT9 QMS Inspection Plans / QT9 QMS Documents
Subpart (a)
Process Specifications
QT9 ERP Bill of Materials / QT9 QMS Inspection Plans / QT9 QMS Documents
Subpart (b)
Quality Assurance Proceduresand Specifications
QT9 QMS Inspection Plans / QT9 QMS Documents
Subpart (c)
Packaging and Labeling Specifications
QT9 QMS Documents / QT9 ERP Bill of Material File Attachments
Subpart (d)
Installation, Maintenance andServicing Procedures
QT9 QMSDocuments
Subpart (e)
FDA Part 820.184 Device History Record Compliance
QT9 Software is your one-stop medical device manufacturing solution. With the power of QT9 ERP and QT9 QMS, you can completely automate your device history records. This gives you the ability to create any device history records current or past at the click of a button.
Quantity Manufactured
Quantity Releasedfor Distribution
QT9 ERP Job / Inventory Transactions Subpart (c)
The Acceptance records which demonstrate the DMR
QT9 QMS Inspections / QT9 QMS Documents / QT9 ERP Job Routing Verification Subpart (d)
Electronic Device Master Records (eDMR)
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 Master Records.
Sign in online anytime, anywhere to get a real-time view of your device master records.
Built-In Dashboard
Quickly see the status of IATF 16949 items with real-time reports from the QT9 dashboard.
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.