What are the solutions for the pharmaceutical and medical device industry?
The pharmaceutical industry is facing unprecedented uncertainty, and an architecture that integrates business and digital strategies needs to be instilled throughout the company (management, R&D, supply chain, production, patient services, and support functions). That is what is required.
Strategic integration of architectures not only improves the efficiency of internal operation costs, but also creates new businesses and builds and develops ecosystems.
Features
We provide GMP education to project personnel of our customers in the pharmaceutical and medical device manufacturing industry, and form a project team of project managers, consultants, and engineers familiar with GxP systems to provide services.
Click here for useful columns for the pharmaceutical and medical device manufacturing industry.
B-EN-G integrates Level 2 (Monitoring and Control) to Level 4 (Business Planning) of the ISA95 Model.
In the integration of each layer, by establishing global standards for each layer system components and interconnecting them through Plug and Produce, we can identify risks according to the manufacturing process of each drug from the development stage and permanently manage those risks during commercial production. will be introduced.
We have extensive experience in roll-out and roll-in projects in line with global business expansion in the pharmaceutical and medical device manufacturing industry.
The solutions such as various system templates that B-EN-G has built based on our track record are fully equipped with various documents in Japanese and English.
Related solutions
Waters NuGenesis LMS
A system that centralizes all data related to quality testing, consisting of a scientific information data management system and an electronic laboratory notebook.
Ethics/Volunteer System
Solutions that cover everything from ethics applications to volunteer recruitment and implementation of samples needed for research
Computerized system validation (CSV) support service
Support for system assessment, development work, maintenance of operational procedures, and verification work for pharmaceutical manufacturers.
CSV on AWS(Computerized System Validation on Amazon Web Service)
A service that provides solutions for the pharmaceutical manufacturing industry using the AWS cloud environment.
Cloud qualification service
Support for CSV of infrastructure part when cloud service is adopted
Pharmaceutical research and development data integration platform construction support
Supporting the construction of a research and development data integration platform that helps improve and speed up the development process of new products
SAS manufacturing solutions
Software from SAS Institute (USA) that can perform data analysis, statistical analysis, and visualization of analysis results.
Asprova APS (SAP collaboration for pharmaceutical manufacturing industry)
A solution that optimizes small schedule planning by linking with SAP's manufacturing scheduling function
PAS-X MES
Manufacturing execution system specialized for the pharmaceutical industry provided by Kerber Pharma (Germany)
B-EN-Gp
SAP S/4HANA implementation package for the pharmaceutical manufacturing and sales industry that meets both global requirements and Japan-specific requirements
B-EN-Gp JD-NET Solution for SAP S/4HANA
SAP S/4HANA sales logistics solution linked with JD-NET (EDI for the pharmaceutical industry)
mcframe Solutions for the pharmaceutical industry
mcframe 7 template for pharmaceuticals, which has a good track record of being used in generics.
Case Study
neo CritiCare Pharma Co., Ltd.
Implement multiple modules in a short period of time SAP S/4HANA implementation project example by B-EN-Gp
Sakamoto Yakuhin Kogyo Co., Ltd.
Manufacturing execution system specialized for the pharmaceutical industry PAS-X MES implementation example
Idorsia Pharmaceuticals Japan Ltd.
Compatible with global requirements JD-NET compatible sales management system construction project example
Topics
Useful materials
