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Fujirebio Diagnostics Implements Paperless Electronic Initiative for its Biomarker Manufacturing
技术
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 生命科学
适用功能
- 质量保证
- 离散制造
用例
- 自动化制造系统
- 预测性维护
服务
- 系统集成
- 软件设计与工程服务
挑战
Fujirebio Diagnostics, a trusted source of innovative solutions in clinical diagnostics, was facing challenges with its existing paper-based GMP record system and manual process. The company was spending significant time each day manually reviewing reports. The paper-based system was not only time-consuming but also vulnerable to reporting errors. Moreover, any new system implemented had to enable the company to remain in compliance with federal regulation.
关于客户
Fujirebio Diagnostics, Inc. is a global partner of choice among leading diagnostics companies around the world. With a reputation of more than 20 years as a trusted source of innovative solutions in clinical diagnostics, Fujirebio’s proven manufacturing process for the production of biomarkers has made it a global partner of choice among leading diagnostics companies around the world. Being in the life sciences industry, Fujirebio adheres to a strict manufacturing process which is based on Wonderware by AVEVA. These processes are certified with compliance for reporting and documentation requirements that are very detailed and extensive. The biomarkers produced by Fujirebio help physicians, lab professionals and patients better manage disease. Over the course of the year, Fujirebio’s 160,000- foot production facility produces about 75 million tests that are distributed throughout the world. It is a FDA-registered facility that is 21 CFR Part 11 compliant, and is both ISO 9001 and ISO 13485 certified for quality systems.
解决方案
Fujirebio implemented AVEVA's System Platform, Workflow Management, Historian, and InTouch HMI to replace its existing paper-based system. The solution, called the Electronic Initiative and the first phase of the implementation is called the Equipment Monitoring System (EMS), allows personnel to monitor equipment from their workstations, maintains all temperature readings in electronic records, notifies authorised personnel in the event of adverse temperature trends, generates electronic Good Manufacturing Practice (GMP) reports for review by exception, and provides authorised personnel electronic signature capabilities to approve reports. The EMS system at Fujirebio performs a number of very important functions. Workflow Management is at the heart of Fujirebio’s EMS. What Workflow Management does is digitise and automate Fujirebio’s manual processes that include people, equipment and systems, based on a sophisticated Business Process Management (BPM) foundation standard. This enables staff to generate electronic records and file them automatically.
运营影响
数量效益
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