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Life Sciences
How EnteGreat Helps Our Life Sciences Manufacturing Clients Achieve Their Goals
EnteGreat is working with manufacturers in the Pharmaceutical, Biotech, and Medical Device sectors to help them effectively deal with important issues in manufacturing, quality, and supply chain management, to achieve the outcomes they want while also avoiding the risks and pitfalls that inhibit success. To learn more, please click on the links below.
- Helping clients to bridge the organizational and information silos between Development, Manufacturing, and Quality
- Applying Lean techniques to the commercialization value chain, including the use and re-use of standardized process elements to streamline the commercialization time line
- Implementing a platform of systems, processes, and models, along with the organizational discipline to make significant gains in commercialization time and cost
- Engaging enabling technologies that accelerate analysis, transformation, feedback, and information management within the commercialization value chain
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- Enforce compliance at the point of use in manufacturing with the right systems
- Reduce quality assurance review cycles for product release by changing the paradigm to quickly and accurately identifying and resolving exceptions
- Apply Lean approaches to compliance by reducing non-value adding activities and focusing on Critical To Quality
- Build compliance management processes that manage the interdependent elements (i.e.: validation, training, and documentation) with full traceability through the compliance cycle
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- Establish predictable and reliable manufacturing as part of an enabled supply chain, focused on responsiveness and fulfillment
- Streamline manufacturing quality assurance cycles through the adoption of Electronic Batch Record (EBR) systems that support product dispositioning and release by exception
- Develop and implement efficient Sales and Operations Planning (S&OP) processes that incorporate continuous process improvement mechanisms
- Enable manufacturing visibility to drive enterprise-level supply chain coordination and plant-based operational performance against plan
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- Utilize value stream analysis and mapping as well as Lean manufacturing techniques to drive operational performance
- Support operations excellence programs, such as Overall Equipment Effectiveness (OEE), downtime monitoring, Statistical Process Control (SPC), and waste reduction
- Reduce the time and expense associated with excursions and exception investigations through automated data collection and integration with process historians
- Apply PAT methods to support appropriate data collection and analysis systems for process analysis, improvement, and understanding
- Incorporation of best practices, operational excellence programs, and continuous improvement approaches from other manufacturing sectors such as Food, Beverage and Consumer Packaged Goods (CPG)
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- Alignment of people, processes, and systems through manufacturing and supply chain improvement initiatives
- Engagement of holistic change management programs to deliver manufacturing and supply chain solutions that drive sustainable business benefits
- Deployment of enforced manufacturing compliance programs that comprehensively engage manufacturing stakeholders through the program lifecycle
- Application of standards-based programs for defining manufacturing operations and processes that comprehensively align work roles and responsibilities, training, documentation, and systems requirements
- Drive transformational change programmatically to achieve end-user adoption, process entrenchment, and long-term sustainment
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EnteGreat Enablers
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