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Making Waves in Regulated Manufacturing Industry
Like many industry catch phrases before it, "manufacturing informatics" sounds impressive, but is not yet widely recognized nor understood. Eastlake, Colo.-based Aegis Analytical Corporation wants to change that by making the concept of manufacturing informatics as well-known as total quality management, six sigma or just-in-time manufacturing. The Company Founded in 1996, privately held Aegis develops software solutions that allow manufacturers to get higher product yield and quality out of their existing manufacturing plants and equipment by analyzing the large amounts of strategically important data they already gather and store in corporate databases, a technology Aegis calls manufacturing informatics. Aegis' initial target market includes regulated manufacturers of pharmaceutical, biotechnology and medical device products. Later market expansion includes manufacturers of food, chemical, petrochemical and other products made by regulated or capital-intensive manufacturing processes. These types of businesses are under increasing pressure from customers and regulatory authorities to provide the highest level of product safety, quality and consistency. They also face stiff competition, resources constraints and cost containment. The Challenge "All manufacturing companies experience global pressures to improve competitiveness through increased productivity," said Gretchen L. Jahn, president and chief executive officer of Aegis Analytical Corporation. "However, manufacturing companies subject to government regulations, such as those imposed by the Food & Drug Administration (FDA), experience significant additional constraints. For example, significant changes cannot be made to the manufacturing process without risking the cost of a new set of clinical trials or re-approval of the process. Because of these increased pressures, Aegis is first targeting highly regulated companies with its manufacturing informatics software systems." The Situation Aegis' first product, Discoverant, is a software system that evolved to satisfy the complex manufacturing failure analysis and process improvement needs of FDA-regulated manufacturers. Discoverant, which runs on Windows NT and Unix-based computing platforms, is a stand-alone, domain-specific data mining and information discovery system that addresses a significant need for process improvement in regulated manufacturing operations. These manufacturers, which include pharmaceutical, biotechnology and medical device companies, have unique needs for batch process data analysis. Such a requirement demands powerful statistical analysis, pattern recognition and data visualization capabilities, combined with interactive connectivity to several disparate manufacturing-related data sources. Discoverant improves the management and tracking of process changes and allows better compliance with increasingly stringent regulatory requirements for process validation, trend analysis, change control and documentation. The Solution Rather than reinventing the wheel and trying to develop Discoverant's data analysis and visualization engine from scratch, Aegis conducted an exhaustive search of commerically available products that offered these capabilities. The company chose PV-WAVE® from Visual Numerics, Inc. "We needed a very robust graphics and visualization engine that was capable of handling large amounts of data very efficiently," Jahn said. "Our software [Discoverant] needed to have an application programmer interface or callable interface, with easy methods for passing data and receiving results. Three- and four-dimensional visualizations are also a key requirement of our customers. We had a substantial list of requirements and PV-WAVE met a large majority of them." PV-WAVE, Visual Numerics' flagship product, is an array-oriented fourth-generation programming language (4GL) used by engineers, scientists, researchers, business analysts, and software developers to build and deploy visual data analysis (VDA) applications. These applications let users visualize and manipulate complex or extremely large technical datasets to detect and display patterns, trends, anomalies, and other vital information. The software includes hundreds of mathematical and statistical routines from the IMSL Numerical Libraries, as well as image processing, signal processing, mapping, and general data manipulation features. The Results Jahn said PV-WAVE provides significant value to Discoverant users not only because of its powerful visualization tools, but also the strong data analysis capabilities offered by the IMSL Numerical Libraries. "We use a number of the IMSL statistical routines and we are partnering with Visual Numerics to define other numerical analysis routines that will extend Discoverant as a solution to additional problems." PV-WAVE's flexibility also scored points with Jahn. "We have found PV-WAVE to be highly versatile. We have been able to create new ways of viewing and understanding complex data interactions that provide significant insights to our users. Our customers have been very impressed with the quality of output they can produce in a short period of time using Discoverant with the embedded Visual Numerics' products." For more information about Aegis Analytical Corporation or Discoverant, visit the company's Website at www.aegiscorp.com Additional information about Visual Numerics and PV-WAVE is available at www.vni.com.
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