StatSoft, Inc., has announced 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.