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 QMS and QT9 ERP software. Master regulatory compliance and ensure the accuracy and integrity of your data with only EBR software that seamlessly integrates quality data into your EBR processes.
Modernize batch records
Streamline your device records
Get FDA & cGMP compliance
Simplify quality processes
Centralize doc control
Get traceability & accuracy
Access real-time analytics
Automate Batch Records with EBR Software
Benefits of EBR software
Get started with features designed to build powerful batch records management.
Centralize Your Data
Connect 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 customer 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 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.
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 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 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.
Connect all the tools you use for electronic batch records
QT9 QMS enables you to integrate multiple business processes with electronic device history records.
Pre-validated QMS software
QT9 QMS is pre-validated for accelerated compliance.
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FDA and ISO compliance out-of-the-box
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Rapid cloud deployment for faster implementation
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Audit-ready with timeline traceability
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Electronic signature approvals and secure access controls
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Continuous validation and updates
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• ISO 13585 |
• FDA 21 CFR Part 11 |
QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
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Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
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Reduces downtime waiting for your QMS to be approved for use.
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Minimizes the risk of any failed audits due to flawed validation protocols.
See what quality leaders say about QT9 QMS
FAQs: EBR Software
Electronic batch record (EBR) software is a digital solution that replaces paper-based production records with automated, real-time documentation. EBR software helps manufacturers track, manage and store batch data electronically to improve compliance, reduce errors and speed up batch release.
EBR software ensures data integrity and traceability by capturing time-stamped records that serve as proof that each product meets required specifications and was produced under controlled conditions. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) and Health Canada, require manufacturers to maintain complete, traceable records for each batch.
Industries with strict regulatory requirements, such as pharmaceuticals, life sciences, biotechnology, medical device, cosmetics, food and beverage, and chemicals, commonly use EBR software to streamline documentation and improve batch traceability.
QT9 QMS EBR software allows companies to manage batch records in real time from any location. Benefits include:
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Automated data capture and validation
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Integration with production and quality processes
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Real-time traceability and audit readiness
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Reduced manual entry and human error
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Faster review and approval cycles
Yes. QT9 QMS is a cloud-based platform that enables secure access to batch records from anywhere, with automatic updates and minimal IT overhead. It also offers an on-premise option for companies requiring local deployment.
Yes. QT9 QMS EBR software is fully compliant with 21 CFR Part 11. It includes electronic signatures, secure audit trails and controlled user access to meet FDA and global regulatory agency standards.
Quality management resources
Shop Floor Management Software Drives Productivity and Compliance for Life Science Manufacturers
FDA QMSR 2026: Complete Guide to Replacing the FDA QSR (21 CFR Part 820)
ISO 9001:2026 Revision Guide Timeline, Key Changes and Preparation Steps
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