About Solutions for the Pharmaceutical and Medical Device Industry
The pharmaceutical industry is facing unprecedented "uncertainty" and requires an architecture that integrates business and digital strategies across the enterprise (management, R&D, supply chain, production, patient services, and support functions).
Strategic integration of architectures not only streamlines internal operating costs, but also creates new business and builds and develops ecosystems.
Features
We provide GMP training for project personnel working for clients in the pharmaceutical and medical device manufacturing industries, and organize project teams of project managers, consultants, and engineers who are 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 integrating each layer, we will introduce a mechanism to identify risks associated with the manufacturing process of each drug from the development stage by globally standardizing each layer's system components and interconnecting them with Plug and Produce, and to permanently manage those risks during commercial production.
We have extensive experience in roll-out and roll-in projects in line with the global expansion of the pharmaceutical and medical device manufacturing industry.
Based on our experience, B-EN-G has built various system templates and other solutions, complete with a variety of 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
Assisting through all phases of the validation life cycle: Requirements Gathering, Risk Assessment, Validation and Training, Change Management consulting, and System Retirement.
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 Development Support
Supporting the construction of a research and development data integration platform that helps improve and speed up the development process of new products
Solution for analyzing causes of deviations from standards
A service that uses AI and DAG (Directed Acyclic Graph) to support customer decision-making
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)
BatchLine
Electronic Batch Record (EBR) Solutions for Pharmaceutical and Medical Device Manufacturers
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
Sakamoto Yakuhin Kogyo Co., Ltd.
Manufacturing Execution System Specialized for the Pharmaceutical Industry: PAS-X MES Case Study
Idorsia Pharmaceuticals Japan Ltd.
Compatible with Global Requirements: Case Study of a Project to Build a Sales Management System Compatible with JD-NET
GE Healthecare Pharma Limited
Promoting Understanding among Global IT Teams: JD-NET-compliant Enterprise Resource Planning System Implementation Project Case Study
Topics
Useful Resources
