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
EBR compliance made easy for life science companies
QT9 QMS is a fully-validated platform
We do all the software validation for you. No extra charge.
1,000+ of the world's leading companies trust QT9
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.
-
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.
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.
See what quality leaders say about QT9 QMS
FAQs: EBR software
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.
Quality management resources
QT9 Software Announces European Data Centre Expansion to Enhance Global QMS Platform Performance
AS9100 to IA9100: Aerospace QMS Prepared for the Future
Top 11 Signs Your Manufacturing Business Needs MRP Software
Try QT9 for free
Ready to simplify your quality processes? No credit card needed.