Electronic batch records are digital records used to document manufacturing activities during batch production. They capture process data and help improve traceability.
Batch records & history for Life Sciences manufacturing
Accelerate batch release and strengthen compliance in pharma manufacturing
Electronic and master batch record, and batch historian capabilities for compliance and visibility
Digitizing batch records and centralizing historical data helps improve traceability, simplify documentation, and provide better insight into batch performance. Electronic and Master Batch Records capture execution data as it happens, while historian capabilities store process and operational information for analysis and review.
Electronic Batch Records (EBR)
Capture batch execution data in a structured digital format with real-time data entry and built-in checks. This supports consistent documentation and improves traceability.
Master Batch Records (MBR)
Define approved batch instructions and process steps to ensure each batch follows a standardized process.
Batch Historian
Store batch data including process parameters, events, and operational records to support historical analysis and batch review.
Integrated Data Capture
Collect batch data directly from manufacturing systems and equipment to reduce manual entry and improve data accuracy.
Better Batch Visibility
Monitor batch status and process data through dashboards and reporting tools that provide insight into production performance.
Support Regulatory Alignment
Supports electronic record management aligned with requirements such as 21 CFR Part 11, helping maintain secure, validated, and audit-ready documentation.
How it improves manufacturing operations
Batch Records & History solutions provide a structured way to manage batch documentation and process data. By capturing production data digitally, manufacturers can maintain a complete and connected view of each batch, supporting compliance, efficiency, and operational excellence.
- Improve batch traceability
- Improve process consistency
- Simplify batch review
- Support data-based decisions
- Improve visibility into operations
New thought leadership
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Blog
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Speed matters in life sciences manufacturing. Competitive pressure, complex product portfolios and evolving regulatory expectations all place increased emphasis on faster, more reliable delivery of new and existing therapies.
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Blog
From data to knowledge: Building workforce intelligence in pharma manufacturing
Pharmaceutical manufacturing generates vast amounts of data. Process values, batch execution details and event histories are captured every day. Yet data alone does not drive improvement.
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eBook
Optimizing pharma manufacturing: An executive guide to Overall Equipment Effectiveness (OEE)
Pharmaceutical manufacturing has never been more complex. The shift toward biologics, personalized therapies, and multi-product facilities demands precision, agility, and rigorous documentation. Yet, many manufacturing leaders still struggle to answer a basic question with confidence: How effectively are our assets actually performing?
Other TrackWise Manufacturing solutions
TrackWise Manufacturing Operations Management Platform is built for Life Sciences manufacturing organizations, combining proven technologies from Honeywell all in one modular platform and single user interface, including:
Recipe authoring & execution
Process visualization & insights
Inventory management
Weigh & dispense
Process automation
Frequently asked questions about batch records & history
A master batch record (MBR) defines the approved steps and instructions required to manufacture a product. It ensures that each batch follows a consistent process.
A batch historian stores and organizes batch and process data over time. It helps manufacturers review past performance and understand production trends.
Digital batch records capture data in real time and reduce manual documentation. This improves visibility into production and simplifies batch review.
A Master Batch Record (MBR) is the standardized template that defines how a product should be manufactured — including materials, equipment, and step-by-step instructions. It serves as the “recipe” for production and ensures consistency across batches.
An Electronic Batch Record (EBR) is the digital execution of that template during actual production. It captures real-time data, operator actions, and process parameters as each batch is manufactured. While the MBR provides the framework, the EBR documents the evidence of execution, creating a complete, compliant, and audit-ready record.
Electronic Batch Records support compliance by aligning with regulatory requirements such as 21 CFR Part 11 and GMP guidelines. They provide secure, validated documentation with audit trails, electronic signatures, and exception-based review. This reduces manual errors, ensures data integrity, and makes it easier to demonstrate compliance during inspections. By digitizing records, manufacturers can accelerate batch release, reduce QA review time, and maintain audit readiness across pharma, biopharma, medical device, and CDMO/CRO operations.
