Accelerate Batch Release and Strengthen Compliance in Pharma Manufacturing
Pharma, Biopharma, Medical Device, and CDMO/CRO manufacturers must maintain accurate batch records while managing complex production processes. Paper-based documentation and disconnected systems often make it difficult to access batch data, track execution, and maintain consistent records.
Batch manufacturing requires detailed documentation of process steps, parameters, and quality checks. When this information is stored across paper records or multiple systems, it becomes harder to maintain consistency and retrieve data when needed.
Limited access to batch history can delay reviews and make it difficult to understand how a batch was executed.
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.
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.
Define approved batch instructions and process steps to ensure each batch follows a standardized process.
Store batch data including process parameters, events, and operational records to support historical analysis and batch review.
Collect batch data directly from manufacturing systems and equipment to reduce manual entry and improve data accuracy.
Monitor batch status and process data through dashboards and reporting tools that provide insight into production performance.
Supports electronic record management aligned with requirements such as 21 CFR Part 11, helping maintain secure, validated, and audit-ready documentation.
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.
EBOOK
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?
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:
Electronic batch records are digital records used to document manufacturing activities during batch production. They capture process data and help improve traceability.
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.
