BUSINESS SOLUTIONS / IndustriesPharmaceutical, Medical Equipment
- Changing Healthcare Environment
- The healthcare industry is undergoing drastic changes of late, due partly to mergers/consolidations within the pharmaceutical industry to prepare for massive R&D investments, partly to the impact of government measures to curve rising medical costs and thereby support the aging population, and partly to the progress of managed care in medical services.
- Value Chain Reform and Strict Regulatory Compliance
- Drug manufacturers and medical device manufacturers are required to drive value chain reform, in order to accelerate spin-off of production operations, increase contract manufacturing, utilize CRO, and outsource logistic processes. Medical institutions are also shifting to networked care, where different municipalities collaborate with one another in offering efficient medical care. At the same time, manufacturers must continue to implement advanced quality control to comply with the requirements of FDA 21 CFR Part 11, revised Pharmaceutical Affairs Law, GMP and various other laws and regulations.
- Providing Services Backed by Proven Track Records
- B-EN-G has handled a number of projects with many drug manufacturers and medical device manufacturers. Accordingly, we are familiar with the requirements specific to the industry, advanced quality control systems such as lot tracing, and what needs to be done to quickly address compliance issues. We provide a range of services reflecting our wealth of expertise.
Specific Examples of Consulting and System Implementation
- Examination support on ERP package selection (consulting in the planning stage)
- Consulting on ERP implementation
- System integration after merger/acquisition
- System implementation to local operation after overseas production shift
- System modification after spin-off of factory operation
- Sales & distribution system modification and supply chain reform after outsourcing of logistics processes
- Implementation of knowledge-based management system to improve MR productivity
- Validation support
- Implementation of system to medical institution for accelerating clinical trials
- Implementation of warehouse management system to pharmaceutical company
The above are representative examples. This is not a comprehensive list.
- B-EN-G's solution that supports implementation of SAP ERP to pharmaceutical companies.
- A pharmaceutical solution incorporating various functions addressing the requirements specific to this industry, such as compliance with FDA 21 CFR Part 11, quality control conforming to the GMP standards, and content correction and foolproof functions.