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Electronic batch record for manufacturing

Electronic batch records (EBRs) in modern manufacturing deliver a comprehensive audit trail for every batch, replacing traditional paper forms with a self-auditing process that eliminates costly paperwork errors and the need for manual record reviews.

What is an electronic batch record?

An electronic batch record (eBR) provides a complete manufacturing audit trail of every manufacturing batch produced. It replaces paper batch record forms with a self-auditing batch record process that eliminates costly paperwork errors and the requirement to review batch records manually. You can access electronic batch record data online and batch record throughput times are much shorter, with reduced risk of non-compliance.

Electronic batch record software helps to ensure manufacturing control by reducing scrap, batch paperwork errors and redundant checks. It offers the flexibility to model and change complex processes based on the master batch record and the real-time feedback needed to quickly identify and resolve batch record issues that inhibit process and product improvement. eBR software manages a wide variety of processes, including personalized and autologous therapies, bio-diagnostics (reagents and instruments), assays, and others.

Electronic batch records must be fully 21 CFR Part 11 compliant, with electronic signatures and full-data integrity and retention. As the system creates the electronic batch record, it enforces the master batch record. The electronic batch record features comprehensive product and process tracking and control, including processes and equipment used, quality data, test results, non-conformances, materials consumed, process yield, operator signatures, and dates and times.

Life Sciences manufacturers face daily challenges in securing and maintaining a profitable, growing business despite strict regulations, global competition, and the need for customized products. Top Pharma and Biotech companies use electronic batch record software to reduce operating and compliance costs, improve quality and consistency, and shorten time-to-volume product cycles.

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Understand the benefits

Enhance audit trail and data accessibility

Ensure enhanced transparency and traceability with a comprehensive audit trail accessible online for every manufacturing batch. This trail facilitates quick retrieval and analysis and minimizes the need for manual record reviews.

Eliminate errors and ensure compliance

Eliminate costly paperwork errors and ensure regulatory compliance by incorporating electronic signatures, maintaining data integrity, and adhering to standards such as 21 CFR Part 11.

Improve process and operate efficiently

Contribute to shorter throughput times, get real-time feedback, and gain flexible process modeling, facilitating continuous process improvement in manufacturing.

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Discover more about Opcenter Execution Pharma

The platform that helps you win the race against time provides electronic batch records for the pharmaceutical industry.