STATISTICA Enterprise™ Helps Enhance the Operational Process Flow at a Medical Device Manufacturer
公司规模
1,000+
国家
- United States
产品
- STATISTICA Enterprise
- GEM Premier™ 4000 analyzer
- GEMweb® Plus Custom Connectivity
- ACL TOP® Family of Hemostasis Testing Systems
- HemosIL line of hemostasis reagents
技术栈
- Web browser-based reporting tool
- Analytics server platform
- Standard analysis templates
- Report templates
实施规模
- Enterprise-wide Deployment
影响指标
- Cost Savings
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 分析与建模 - 预测分析
- 分析与建模 - 实时分析
- 应用基础设施与中间件 - 数据交换与集成
适用行业
- 医疗保健和医院
- 生命科学
适用功能
- 流程制造
- 质量保证
用例
- 质量预测分析
- 过程控制与优化
- 远程资产管理
服务
- 软件设计与工程服务
- 系统集成
关于客户
Instrumentation Laboratory, founded in 1959, is a worldwide developer, manufacturer, and distributor of in vitro diagnostic instruments, related reagents, and controls for use primarily in hospitals and independent clinical laboratories. The company’s product lines include critical care systems, hemostasis systems, and information management systems. Instrumentation Laboratory’s products include the GEM Premier™ 4000 analyzer with Intelligent Quality Management (iQM®), GEMweb® Plus Custom Connectivity, the ACL TOP® Family of Hemostasis Testing Systems, and the HemosIL line of hemostasis reagents. Instrumentation Laboratory employs more than 1750 employees worldwide and is a wholly-owned subsidiary of the global healthcare corporation Werfen Group.
挑战
Instrumentation Laboratory faced challenges integrating and accessing data from various systems for quality control of its manufacturing process. The complexity of medical device manufacturing and testing involves large amounts of data from suppliers, manufacturing processes, product testing, and field performance. The data are stored in different file formats and use different terminology, making it difficult and time-consuming for engineers and management to access and analyze the data. To address these challenges, Instrumentation Laboratory investigated the utility of a Web browser-based reporting tool and portal with links to static and interactive reports analyzing data from disparate databases.
解决方案
STATISTICA Enterprise streamlines collaboration so that engineers and managers work from a common platform, file format, and terminology. Consequently, they can now answer questions immediately, perform interactive investigations, and explore processes and product testing regardless of where the data are stored. These benefits translate to tangible savings for Instrumentation Laboratory. The company has incorporated STATISTICA Enterprise into its manufacturing process for standard data access and as its analytics server platform. A standard set of connections to data sources and automated analyses and reports enable engineers to focus on analyzing results, collaborating, and problem-solving instead of hunting down data. STATISTICA Enterprise streamlines the data analysis components of process validation and automates common reports and analyses. Leveraging STATISTICA’s set of standard analysis templates and report templates, Instrumentation Laboratory now has a common set of “views” of their processes, tests, and product performance results. The utilization of the STATISTICA Enterprise Server software platform is a foundation component for its adherence to the process control and statistical analysis guidance aspects of the FDA’s 21 CFR Part 820 for medical device manufacturers.
运营影响
数量效益
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