STATISTICA Enterprise™ Analytics Software Helps Enhance the Operational Process Flow at Instrumentation Laboratory, a Global Medical Device Manufacturer

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Instrumentation Laboratory, a global medical device manufacturer, faced challenges integrating and accessing data from various systems for quality control of its manufacturing process. The company selected StatSoft's STATISTICA Enterprise data analytics solution to address these issues because Enterprise allows its engineers and managers to collaborate across a common platform, file format, and terminology.

image of GEM Premier™ 4000 analyzer

Instrumentation Laboratory's GEM Premier™ 4000 analyzer is one of the products whose manufacture benefits from the use of StatSoft's STATISTICA Enterprise software.

We have incorporated STATISTICA Enterprise into our manufacturing process...The automated analyses and reports enable the engineers to focus on analyzing results, collaborating, and problem solving instead of hunting down data.

StatSoft, Inc., announces that its STATISTICA Enterprise software solution provides Instrumentation Laboratory with a multi-user data analytics platform that simplifies and ensures quality in the manufacturing process while strengthening collaboration across departments.

Instrumentation Laboratory, a global medical device manufacturer, faced challenges integrating and accessing data from various systems for quality control of its manufacturing process. “Medical device manufacturing and testing is complicated, with large amounts of data from suppliers, manufacturing processes, product testing, and field performance,” says Rob Eames, Director of StatSoft’s Life Sciences Practice.

Because the relevant data are stored in different file formats and even use different terminology, the task of accessing and analyzing the data was difficult and time consuming for both engineers and management. 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.

Instrumentation Laboratory selected STATISTICA Enterprise to address these issues because Enterprise allows engineers and managers to collaborate across a common platform, file format, and terminology. In the past, engineers and analysts had invested a considerable amount of time simply obtaining relevant data and then determining how to analyze it. STATISTICA Enterprise streamlines the data analysis components of process validation and automates common reports and analyses.

“We have incorporated STATISTICA Enterprise into our manufacturing process for standard data access and as our analytics server platform," notes John Young, business analyst at Instrumentation Laboratory. "A standard set of connections to our data sources and the automated analyses and reports enable the engineers to focus on analyzing results, collaborating, and problem solving instead of hunting down data.”

Leveraging STATISTICA’s set of standard analysis and report templates, Instrumentation Laboratory now has a common set of “views” of their processes, tests, and product performance results. Consequently, the engineers and managers 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.

Instrumentation Laboratory’s utilization of the STATISTICA Enterprise Server software platform is also 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.

ABOUT STATISTICA AND STATSOFT
Founded in 1984, StatSoft, Inc, is one of the world’s largest providers of analytics software, with 30 offices around the globe and 1 million+ users of STATISTICA software. StatSoft provides Enterprise Manufacturing Process Intelligence software solutions to help companies in a variety of industries better meet the high standards of control, monitoring, and documentation mandated by strict regulatory frameworks and to improve product and process outcomes. With its STATISTICA suite of quality control and analytics tools, StatSoft is a trusted partner of the world’s largest life sciences companies, helping them reduce the time and cost of analyses, improve accuracy, reduce risk, and streamline workflows.

ABOUT INSTRUMENTATION LABORATORY
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.

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Dymian Kritikos
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