Production Batch Record – Part 2: Electronic Batch Record

In the previous post, SEN Pharma pointed out some limitations of paper batch records, which include lower accuracy, the undetected impact on the environment, and a high consumption of storage space. One of the modern technological solutions to these problems is using Electronic Batch Record (EBR).

Electronic Batch Record is a tool that allows responsible employees to create, fill out, save, and retrieve every information and data in production steps consecutively and systematically. The data is entered on the electronic device with specific proofs, such as equipment parameters, raw materials, supplies, manipulations, problems during manufacturing, meeting the requirements about accuracy and transparency of GMP.

Thanks to the data integration and automatic dataset comparison, EBR is such a good system for pharmaceutical companies to reduce material loss, optimize streamlined processes, and efficient operations.

Some benefits of EBR application in pharmaceutical industry can be easily identified:

Increasing data accuracy and consistency by:

Minimizing errors caused by manual data input
Applying automatic and precise timing programs without the need of manual intervention.

Increasing productivity as well as the ability to scale up:

With a professional interface and integration system, EBR provides information to every department quickly, thereby improving the efficiency of communication and cooperation between departments.
Information is accessed quickly and continuously, creating a connection and overview of an event or issue, optimizing the time and providing solutions faster.

Time savings:

In a production cycle, incidents or deviations are detected late, usually when QA officers review the batch records, resulting in double the reprocessing or rework time. In contracts, EBR can alert the parties to the issues immediately, right at the time deviations are detected.

Money savings:

Automated systems can reduce redundant processes, reworking, labor costs, and other small daily expenses such as printing, storage, etc.

Convenience in management:

Management of operators and equipment: All operators must have an ID and password, take responsibility, and verify their entering data and actions.
Data recovery: The electronic system is set up to periodically back up and restore data when problems occur.

Considering the costly investment in setting up systems, buying equipment, and training staff to use EBR, the benefits of EBR and the capacity to avoid risks totally make EBR a good proposition for production and quality systems.

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