Electronic Batch Record (EBR) Software Made Easy
Still filing paper batch records? You’re not alone. If you’re a regulated manufacturer looking to simplify production documentation, meet QT9 QMS. Our EBR software helps you go digital, stay compliant and get real-time insights — without the usual headaches.
With QT9 QMS and QT9 ERP, you can create EBRs and MBRs in one click, master regulatory compliance, and ensure the accuracy and integrity of your data — all with the only EBR software that seamlessly integrates quality data into your 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
The biggest challenges manufacturers face with batch records
Still relying on paper, spreadsheets, or disconnected systems? Here are four common pain points that slow down compliance and production — and how QT9 EBR software helps solve them.
Paper Records = Lost Time & Errors
Manual batch records and spreadsheets cause delays, mistakes, and headaches during audits.
How QT9 helps: Go paperless and centralize records to eliminate manual entry and reduce compliance risk.
Poor Traceability & Audit Readiness
When every lot, signature, or revision isn’t easy to find, audits become stressful.
How QT9 helps: Automatic time-stamped audit trails and lot/serial traceability keep you audit-ready at all times.
Complex Regulations (FDA, ISO, GMP)
Keeping up with FDA 21 CFR, ISO, and GMP requirements is overwhelming without the right system.
How QT9 helps: Pre-validated compliance tools with e-signatures and revision control streamline regulatory readiness.
Disconnected Systems & No Real-Time Insight
Data spread across silos means you can’t see what’s happening until it’s too late.
How QT9 helps: Integrated dashboards connect quality, production, and inventory data for smarter, faster decisions.
Benefits of Electronic Batch Record (EBR) Software
Streamline compliance, eliminate paper and gain real-time visibility with features built to simplify batch record 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.
ERP compliance portal for regulated industries
Digitize device history records (DHR/MDR) and batch records (MBR/EBR) in one secure system. Trusted by medical device and pharmaceutical manufacturers across the U.S. and worldwide.
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Authorized auditors, inspectors, or compliance officers can securely log in to view or print compliance data — including MDR, DHR, MBR and EBR — without exposing unrelated ERP modules.
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This isolated audit view minimizes compliance risks, safeguards sensitive operational data and ensures faster inspections.
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Automatically compiles all required components — BOMs, routings, QMS documents, inspection data, job travelers and approvals — into one validated report.
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Eliminates manual data collection, reduces human error and saves manufacturers valuable time in preparing device and batch records.
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Seamlessly integrates with the QT9 QMS, ensuring MDR/DHR and MBR/EBR always reflect the latest approved documents, inspection plans, and production data.
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Guarantees only current revisions of controlled documents are included, maintaining full traceability and compliance.
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Automatically links production jobs, BOMs, materials, inspections, and approvals to each generated record.
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Helps manufacturers comply with FDA 21 CFR Part 210/211/820, ISO 13485 and GMP requirements.
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Provides a transparent, auditable trail from design through production, supporting both local and global regulatory demands.
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Supports single-level and multi-level record generation for complex assemblies or multi-stage production.
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Ensures visibility across all subassemblies, components, and processes, critical for regulated manufacturing operations.
Pre-validated software platforms
QT9 solutions are 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 platforms include a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
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Eliminates costly internal validation efforts that can take months of staff time or cost thousands in consultant fees.
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Reduces downtime waiting for your platform to be approved for use.
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Minimizes the risk of any failed audits due to flawed validation protocols.
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.
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
ISO 9001 Document Control: Requirements and Best Practices
Returns Management for Manufacturers: Automate Reverse Logistics with QT9 ERP
Turn Data Into Decisions With the QT9 Business Intelligence Tool
Try QT9 for free
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