Electronic Device History Record
Go paperless and create electronic Device History Records (eDHR) and Device Master Records (eDMR) with one click using QT9 QMS and QT9 ERP software. Master regulatory compliance and ensure the accuracy and integrity of your data with the only eDHR software that seamlessly integrates quality data into DHR processes. Generate single-level and multi-level DHRs and DMRs. Take advantage of free validation and a dedicated compliance portal for securely sharing DHR and DMR records with auditors.
Streamline Your Device Records
Ensure FDA & ISO Compliance
Simplify Quality Processes
Centralize Document Control
Capture Traceability & Accuracy
Access Real-Time Analytics
Watch DHR Software Video
See how QT9 helps medical device manufacturers with Device History Records (DHR) and Device Master Records (DMR).
QT9 ERP is a Fully-Validated Platform
Ensure Regulatory Compliance
- FDA 21 CFR Part 820 and ISO 13485:2016 Compliance: Easily document and trace manufacturing specifics for each lot, batch and unit.
- cGMP Compliance: Current Good Manufacturing Practices (cGMPs) require proof of proper handling for every step of medical device production.
- FDA 21 CFR Part 11 Compliance: Review and electronically approve documents with FDA 21 CFR Part 11-compliant electronic signature approvals.
- Compliance Portal: Guide FDA auditors to electronic device history records and device master records with print capabilities.
Optimize eDHR Processes
- Time-Stamped Audit Trail: QT9 automatically stores a timeline of every transaction for traceability.
- Lot Number or Serial Number Traceability: Track every move from initial purchase to shipping.
- Manage Expiration Dates: Receive automated alerts for minimum stock levels and soon-to-expire inventory.
- Multi-Location Inventory Tracking: Integrate data across multiple locations to ensure everyone is connected.
- Multilevel DHR/DMR Generation: Generate single-level and multi-level eDHRs and DMRs for the medical device industry in one-click.
Modernize Device History Records
- Document Control: Go paperless by centralizing your documents with a cloud-based solution that includes revision-level controls.
- Barcoded Inventory Control: QT9 makes it easy to utilize barcodes for inventory accuracy and scanning across operations.
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Inspection Planning: Automate inspection processes with an easy-to-use cloud-based inspection solution.
- Attach Related Files: Track certificates of analysis or compliance with unlimited file attachments on inspection records.
- Real-Time Analytics: Turn data-driven insights into opportunities with real-time interactive dashboards.
FDA Part 820.181 Device Master Record Requirements
With the power of QT9 ERP and QT9 QMS, you can completely automate your device master records.
Subpart (A)
Subpart (B)
Subpart (C)
Subpart (D)
Subpart (E)
Description
Device Specifications
Process Specifications
Quality Assurance Procedures And Specifications
Packing And Labeling Specifications
Installation, Maintenance, And Servicing Procedures
QT9 Module
QT9 ERP Bill Of Materials / QT9 QMS Inspection Plans / QT9 QMS Documents
QT9 ERP Bill Of Materials / QT9 QMS Inspection Plans / QT9 QMS Documents
QT9 QMS Documents / QT9 QMS Inspection Plans
QT9 QMS Documents / QT9 ERP Bill Of Material File Attachments
QT9 QMS Documents
FDA Part 820.184 Device History Record Requirements
With the power of QT9 ERP and QT9 QMS, you can completely automate your device history records.
Subpart (A)
Subpart (B)
Subpart (C)
Subpart (D)
Subpart (E)
Subpart (F)
Description
Date of Manufacture
Quantity Manufactured
Quantity Released For Distribution
Acceptance Records Demonstrating That The Device Manufactured According To DMR
Labeling
UDI or UPC, If Used
QT9 Module
QT9 ERP Job
QT9 ERP Job
QT9 ERP Job / Inventory Transactions
QT9 ERP Job Routing Verifications / QT9 QMS Inspections / QT9 QMS Documents
QT9 ERP Labels / QT9 ERP Job File Attachment
QT9 ERP Labels / QT9 ERP Job File Attachment
Benefits of eDHR Software
Get started with features designed to help you take control of your device history records.
Centralize Your Data
Connect your Electronic Batch Records data in one place and access it at any time.
Get Real-Time Analytics
Make informed decisions with real-time dashboards. Create your own custom views.
Ensure Compliance
Show proof of proper handling, supporting FDA Current Good Manufacturing Practices (cGMPs).
Link Records
Easily link electronic batch records to related documents, audits, inspections, and more.
Error-Proof Production
Identify and mitigate risks associated with batch production and compliance.
Go Paperless
Store and easily access documentation, training, videos, pictures, and more.
Improve Traceability
See a timeline of every action along with lot and serial traceability.
Get More Done
Choose from over 40 pre-built modules to automate and improve efficiency.
Transform How You Manage Device History Records
Avoid the pitfalls of paper processes with QT9's electronic device history record solution. Data is seamlessly integrated from QT9 QMS and QT9 ERP with verification steps and lot approvals. Documentation, inspection plans and file attachments can be synced to your Bill of Materials (BOM) to create a complete eDHR or eDMR in once click. No paper needed. No separate folder structures.
See What Quality Leaders Say About QT9
Reviewed on Capterra
Joshua P.
Plastics Industry
Small-Business (11-50 emp.)
Read the Review
Reviewed on Capterra
Ryan K.
Plastics Industry
Medium-Business (51-200 emp.)
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Michael M.
Plastics Industry
Medium-Business (51-200 emp.)
Read the Review
Frequently Asked Questions: eDMR and eDHR Software
What is a device master record (DMR)?
A device master record (DMR) is a file that includes all information and specifications needed to produce a particular medical device, including processes and materials used, drawings, labeling and packaging, and installation, maintenance and servicing procedures.
A DMR is required by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 820.
What is a device history record (DHR)?
A device history record is a lot-specific version of the device's DMR. An eDHR is a digital version of the traditional DHR.
Device history records are part of Good Manufacturing Practices (GMPs) and are required by international and national regulatory bodies, such as the U.S. Food and Drug Administration (FDA), to show that all requirements of the DMR have been fulfilled. Global regulators require manufacturers to maintain this information for each stage in the medical device’s life cycle.
What is a bill of materials (BOM)?
A Bill of Materials (BOM) is a comprehensive list of all materials and components needed to manufacture or repair a device, as well as directions for how to use them.
A single-level BOM is generally a simple list of assemblies and quantities needed.
A multi-level BOM is a hierarchical description of how each part is assembled. It lists every component of each part, including details such as quantity, part number and cost.