Solutions

Electronic Batch Record (EBR) Solutions for Pharmaceutical and Medical Device Manufacturers

Electronic Batch Record (EBR) Solution for Pharmaceutical and Medical Device Manufacturers:BatchLine Lite MES

BatchLine Lite MES (hereinafter referred to as BatchLine) is a cloud solution provided by BatchLine, a member of the Factory Group, that enables the electronic recording of manufacturing records for the pharmaceutical (medical device) manufacturing industry.

Since 2004, B-EN-G has been providing services to small and medium-sized pharmaceutical companies in global markets such as Asia, Europe, and the United States as a simple and easy-to-use platform that realizes operational efficiency, strengthens quality control, and optimizes regulatory compliance. B-EN-G has started providing services as a BatchLine implementation partner in the Japanese market since 2024. Pharmaceutical manufacturers that handle a wide variety of formulations can easily proceed with the electronicization of manufacturing records.

Overview

BatchLine is a SaaS electronic batch record (EBR) solution.
It reduces the time and effort required to create, review and approve batch records and its rapid deployment and validation methodology ensures smooth implementation while meeting GMP/FDA regulatory compliance requirements, catering to the requirements and budgets of medium to large scale pharmaceutical manufacturers.

function

BatchLine digitizes your production records.

Designed to comply with CFR Part 11, Annex 11, PIC/S GMP, EU and US FDA data integrity guidelines
Real-time reporting and analytics dashboard for factory-wide progress and compliance
Review by Exception for Faster Batch Release
Deviation management and audit trail support
Can be connected to ERP, LIMS, DMS, and manufacturing equipment such as weighing scales

Features

BatchLine is a solution that makes it easy for anyone to achieve digitalization in the pharmaceutical and biotechnology industries in compliance with GxP standards.
The master settings before creating the MBR are simple, so users can easily create and operate MBRs based on them themselves.

Implementation Results

By digitizing paper production records, it becomes possible to visualize the factory status in real time.

■Improvement of quality control and business efficiency

Automatic generation of final batch report
Reduce time spent on exception reviews and QA processes
Check data entry against specifications as it is entered
Shortening time from production to batch release

■ Cost reduction

Reduce operational costs while remaining compliant
Significant reduction in paper-related operational costs (paper costs, printing, filing, storage costs, etc.)
Improved efficiency in searching for deviations, etc., significantly reduced the amount of work required for QA

B-EN-G Implementation Support Services

The pharmaceutical manufacturing execution system (MES) is a system that instructs workers to manufacture in accordance with the contents of the approval documents and records the results of the work. The results of the work are recorded along with the work content, when and who performed it, and if the recorded content is rewritten, it is also recorded who rewrote it and why.

B-EN-G offers two products, "PAS-X" and "BatchLine Lite MES," as MES solutions specialized for pharmaceutical manufacturing.
We propose and support the implementation of MES-related solutions tailored to the challenges faced by each customer.