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Life Sciences manufacturers are feeling new pressure on their operations from many directions. Dynamic market needs, increased compliance requirements, more distributed manufacturing operations, rapid product innovation, Lean manufacturing, and the approaching transition to new IT technology all manifest themselves on the plant floor and throughout the enterprise - and often lead to pleas for new technology solutions. Compliance management, integration, and data utilization are key issues to address in order to improve responsiveness and performance.
Many manufacturing companies recognize that improving corporate performance demands better synchronization with the plant floor. At the same time, moving to a risk-based approach to compliance may require new systems and improved data visibility. For too long, manufacturing has been isolated. Most of the important production data has not been easily accessible, and is therefore not very useful in improving performance. Today, however, feasible solutions are available to drive excellence in manufacturing performance through better manufacturing intelligence and integration.
Real-time Performance Management (RPM) solutions acquire manufacturing data in real-time, establish the operating context for that data, and ensure that it is stored in a manner that makes it accessible at later times for a variety of uses. RPM facilitates the visibility of this real-time manufacturing data to users throughout the enterprise, and includes tools for enhanced decision support and role-based display of performance against operating metrics. Event-based triggers notify all who should be informed when important or unforeseen events take place. These solutions help companies achieve a higher level of manufacturing excellence by allowing them to better leverage their detailed manufacturing information.
In many companies, it falls to IT to envision new business possibilities in concert with the technologies needed to realize them. At the same time, the usual job of reducing the cost of doing business through increased efficiency and productivity cannot be ignored. This paper outlines how modern solutions can support both strategies at the same time.
Bio-pharmaceutical or medical device manufacturers can achieve compliance with FDA and EU/ISO regulations by focusing on specific processes that influence product quality and safety. High-risk processes can be identified using a scientific risk-based assessment, an approach supported by regulatory agencies and industry. By focusing on manufacturing excellence, manufacturers can reduce the cost and time needed to achieve and maintain compliance. A manufacturing performance excellence focus yields better production management and record-keeping, documented compliance with regulations, and profitability, flexibility, and quality [Table 1]. Compliant Manufacturers in the Life Sciences industry pursue excellence in manufacturing operations. Comparable to ARC's Collaborative Manufacturing Management, SAP's Compliant Manufacturing is a vision for how companies participate in an ecosystem or business network, are able to leverage the network's cumulative ability to plan and anticipate demand and supply, ex-ecute plans efficiently and effectively, comply with appropriate regulations, sense meaningful events in real-time, and respond to and learn from ever-changing business conditions. Manufacturing Excellence is a critical aspect of compliant manufacturing operations for regulated industries. Excellent performance is characterized by the ability to react quickly to changing marketplace conditions, to dynamical-ly reflect these changes in production targets, and to efficiently and reliably achieve these targets. It also requires ongoing cost reductions and quality improvement.
In order to achieve manufacturing excellence, manufacturers need to manage based on real-time performance information. Grounded in operations, Real-time Performance Management (RPM) encompasses the processes, methodologies, metrics, systems, and information needed to measure and manage the performance of a manufacturing organization. RPM places particular emphasis on: acquiring and using real-time, plant level, performance and operating data; providing actionable intelligence based on analytics, event triggers, and visibility; KPI support; and, integration to business systems. RPM provides the real-time plant level information needed by the planning and financial reporting/analysis functions of Corporate Performance Management systems.
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