Batch Records & History
for Life Sciences Manufacturing

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.