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Case Studies > STATISTICA Enterprise™ Helps Enhance the Operational Process Flow at a Medical Device Manufacturer

STATISTICA Enterprise™ Helps Enhance the Operational Process Flow at a Medical Device Manufacturer

Technology Category
  • Analytics & Modeling - Predictive Analytics
  • Analytics & Modeling - Real Time Analytics
  • Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries
  • Healthcare & Hospitals
  • Life Sciences
Applicable Functions
  • Process Manufacturing
  • Quality Assurance
Use Cases
  • Predictive Quality Analytics
  • Process Control & Optimization
  • Remote Asset Management
Services
  • Software Design & Engineering Services
  • System Integration
The Challenge
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.
About The Customer
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.
The Solution
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.
Operational Impact
  • Engineers and managers can now work from a common platform, file format, and terminology, enhancing collaboration.
  • The company can answer questions immediately, perform interactive investigations, and explore processes and product testing regardless of where the data are stored.
  • Engineers can focus on analyzing results, collaborating, and problem-solving instead of hunting down data.
Quantitative Benefit
  • Instrumentation Laboratory employs more than 1750 employees worldwide.
  • StatSoft has 30 offices around the globe and 1 million+ users of STATISTICA software.

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