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.
Requirement
Subpart (a)
Subpart (b1)
Subpart (b2)
Subpart (b3)
Subpart (b4)
Subpart (b5)
Subpart (b6)
Subpart (b7)
Subpart (b8)
Subpart (b9)
Subpart (b10)
Subpart (b11)
Subpart (b12)
Subpart (b13)
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
Connect All the Tools You Use for Electronic Batch Records
QT9 QMS enables you to integrate multiple business processes with electronic batch records.
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
"All of our records are now in one location"
QT9 has streamlined our internal auditing process, preparation for regulatory audits, document control and approval, and organizational training. We have been able to reduce our active documents by 30% as unnecessary/redundant documents and procedures have been made more visible through the document review process.
Reviewed on Capterra
Jennifer B.
Medical Device Industry
Small-Business (11-50 emp.)
Read the Review
"Looking forward to using more modules"
The document control feature has improved our ability to find documents and some records when requested for audit or project purposes. Training is much easier to manage. I like being able to link equipment and gages to system documentation in the Document list. The customer service has always been helpful and responds quickly.
Reviewed on Capterra
Bill C.
Medical Device Industry
Mid-Market (51-200 emp.)
Read the Review
"Excellent support, traceability and ease of use."
We are a medical device company and myself, the FDA & ISO auditors liked the traceability, control of documents and everything was there at our fingertips from Management review to Documents to CAR's. QT9 is always responsive to our questions and resolving issues. For the cost, the flexibility, electronic signature and traceability is worth trying out the system.
Reviewed on Software Advice
Reba D.
Medical Device Industry
Director of QA/RA
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.
Try QT9 QMS and ERP for free
Ready to automate your electronic batch records?
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