Electronic Batch Record (EBR) Software Made Easy
Go paperless by creating your Electronic Batch Records (EBR) and Master Batch Records (MBR) with one click using QT9 ERP and QT9 QMS software. Master regulatory compliance and ensure the accuracy and integrity of your data with the only EBR software that seamlessly integrates quality data into your EBR processes.
Streamline Your Batch Records
Ensure FDA & cGMP Compliance
Simplify Quality Processes
Centralize Document Control
Capture Traceability & Accuracy
Access Real-Time Analytics
Watch EBR Software Video
See how QT9 helps pharmaceutical manufacturers with Electronic Batch Records (EBR) and Master Batch Records (MBR).
QT9 ERP is a Fully-Validated Platform
Ensure FDA Compliance
- 21 CFR Part 210 Compliance: Adhere to pharmaceutical minimum standards for manufacturing, facilities and controls.
- 21 CFR Part 211 Compliance: Optimize process controls for finished pharmaceuticals.
- cGMP Compliance: Current Good Manufacturing Practices (cGMPs) require proof of proper handling for every step of pharmaceutical production processes.
- 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 batch records and master batch records with print capabilities.
Optimize EBR Processes
- Time-Stamped Audit Trial: 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 EBR/MBR Generation: Generate single-level and multi-level Electronic Batch Records (EBRs) and Master Batch Records (MBRs) for the pharmaceutical industry in one-click.
Modernize Electronic Batch 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 211.188 Batch Record Requirements
With the power of QT9 ERP and QT9 QMS, you can completely automate your electronic batch records.
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Description
An Accurate Reproduction Of The Appropriate Master Production Or Control Record, Checked For Accuracy, Dated, And Signed
Manufacturing Dates
Identity Of Individual Major Equipment And Lines Used
Specific Identification Of Each Batch Of Component Or In-Process Material Used
Weights And Measures Of Components Used In The Course Of Processing
In-Process And Laboratory Control Results
Inspection Of The Packaging And Labeling Area Before And After Use
Statement Of The Actual Yield And A Statement Of The Percentage Of Theoretical Yield At Appropriate Phases Of Processing
Complete Labeling Control Records, Including Specimens Or Copies Of All Labeling Used
Description Of Drug Product Containers And Closures
Any Sampling Performed
Identification Of The Persons Performing And Directly Supervising Or Checking Each Significant Step In The Operation, Or If A Significant Step In The Operation Is Performed By Automated Equipment
Any Investigation Made
Results Of Examinations Made
QT9 Module
QT9 ERP Job
QT9 ERP Job
QT9 ERP Job
QT9 ERP Job
QT9 ERP Job
QT9 ERP Job / QT9 QMS Inspections / QT9 ERP Job File Attachments
QT9 ERP Job / QT9 QMS Inspections
QT9 ERP Job / QT9 QMS Inspections
QT9 ERP Labels / QT9 ERP Job File Attachments
QT9 ERP Item Master / QT9 ERP Job
QT9 ERP Job / QT9 QMS Inspections
QT9 ERP Job Routing Verification
QT9 ERP Job / QT9 QMS Inspections / QT9 QMS Nonconforming Product
QT9 ERP Job / QT9 QMS Inspections
Benefits of an EBR Software System
Get started with features designed to build powerful batch record management.
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 Batch Records
Automate the way you generate electronic batch records with an integrated EBR system. 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” EBR at your fingertips. EBR's are tied to any revision of your manufactured item’s Bill of Materials. 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.)
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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: EBR Software
What is an electronic batch record?
An electronic batch record is a digital version of the traditional batch record (BR) used in manufacturing pharmaceuticals and other goods. An EBR is a batch-specific version of a Master Batch Record.
At the highest level, MBRs and EBRs can be considered a “recipe” of the elements that go into a manufactured product. Batch 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 ensure quality and efficacy.