A Competitive Approach to Regulatory Compliance in Life ... - Apriso

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The Power to Act Perhaps most important of all, Apriso's Global Manufacturing Suite empowers executives to take action—not just to set objectives, but to drive those objectives down to the plant floor. Apriso's Business Process Management (BPM) software allows “smart work instructions” to be authored as business processes that can be enforced by the system. The authoring of the processes automatically renders a user interface which directs operators step-by-step through the work instructions, reducing variability and errors in execution and enabling Six Sigma processes. The Return on Investment The benefits of a global approach to operational excellence go beyond compliance with regulations. An Aberdeen study found that companies taking steps to standardize KPIs and close the gap between ERP and the plant floor reported significant improvements in operations, including: 5 � Decreased costs � Improved customer satisfaction � Improved control of manufacturing � Improved visibility into plants/factories � Faster order-to-delivery Get There One Plant at a Time While most analysts and best-in-class companies embrace the need for a global approach to MES, the reality is that companies will need to phase in new systems over time. Companies can implement Apriso’s FlexNet operations execution platform tactically to ease an immediate pain point, or broadly and strategically to seize a global competitive advantage. In all cases, the Apriso platform's modular architecture allows life sciences manufacturers to add capabilities quickly and easily down the road. 5 "Global Operational Excellence Benchmark Report: MES and Beyond," Aberdeen Group, May 2006 8 A Competitive Approach to Regulatory Compliance in Life Sciences Manufacturing While most analysts and best-in-class companies embrace the need for a global approach to MES, the reality is that companies will need to phase in new systems over time.
Conclusion Life Sciences manufacturers are designing and manufacturing increasingly complex product with reduced market windows—while at the same time meeting a variety of regulatory requirements both domestically and internationally. In the past, companies have relied on Manufacturing Execution Systems (MES) to control plant floor operations and maintain compliant processes. As market pressures accelerate, however, companies are finding that their current MES is too inflexible and rigid to cope with the realities of today's life sciences marketplace. Apriso's manufacturing operations management solution performs as a next generation MES platform, moving beyond the capabilities of a traditional MES. The solution provides a single, unified view of all manufacturing activities by synchronizing multiple systems via a single platform for managing and deploying compliant processes anywhere in the world. This allows life sciences manufacturers not only to reduce risk of compliance violations and quality failures, but also to proactively manage quality throughout their operations to gain competitive advantages in quality, cost and time-to-market. The end result is improved business performance and improved regulatory compliance. 9 A Competitive Approach to Regulatory Compliance in Life Sciences Manufacturing
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