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Simplifying Complexity Through Process Improvement and Digitization

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Leonardi da Vinci once said, “Simplicity is the ultimate sophistication.” This principle still holds true today and is critical to success within the world’s current business environment. With the constant introduction of new technologies, employees are regularly overwhelmed by increasing organizational complexity and information overload. In business, simplicity is achieved through implementation of efficient and streamlined processes coupled with customized technological solutions. This state can be realized best through a three-step approach: process improvement, process automation/digitization, and change management. This approach can be applied to all areas, including life sciences quality management and manufacturing functional areas, as well as all enabling functions.

Beyond Simply Adding New Tech

Merely introducing new technology will not fix flawed processes; rather, it's likely to exacerbate existing issues. Thus, it's imperative to optimize relevant business procedures before integrating new technology solutions (i.e., digitization in manufacturing) into your organizational framework. Fortunately, there is a trusted and proven approach to effectively optimize existing processes (think life sciences quality management and manufacturing operations). The first step in this approach is to clearly define your current-state processes, followed by articulating desired future states. Once these benchmarks are

established, identify all gaps between the two states, and then prioritize them based on criticality and feasibility. This prioritization lays the groundwork for crafting a targeted action plan aimed at systematically bridging these gaps. Execution of this plan signifies the culmination of your process improvement journey, paving the way for subsequent advancements through automation.

Proven Process Automation Steps

The automation step begins with a thorough definition of system requirements essential to support your optimized processes. Accurate identification of these requirements serves as the linchpin for selecting the most suitable systems to align with the objectives of the organization. Utilizing the developed system requirements as the compass, the subsequent phase entails the strategic selection, implementation, and seamless integration of a chosen system(s) within the organizational framework, such as a digital quality management system (QMS). The selection process demands a comprehensive and impartial comparison of available options against the stipulated requirements, culminating in a decisive organizational decision on the preferred solution.

Once the decision is solidified, the focus shifts to devising and executing a comprehensive implementation and integration strategy tailored to the organization's unique needs and objectives. The implementation strategy is designed to ensure the smooth installation and customization of the new technology, precisely aligning it with specific business processes and functional groups, such as manufacturing process automation. This involves detailed planning and execution methodologies aimed at facilitating a seamless transition while minimizing disruption to ongoing operations. Simultaneously, the integration plan assumes a distinct role, focusing on orchestrating the cohesive coexistence of the new technology with pre-existing systems and software infrastructure. This entails meticulous planning and execution to ensure interoperability, data consistency, and optimal performance across the integrated ecosystem. Recognizing the critical importance of integration planning and execution, meticulous attention must be dedicated to maximizing the potential of the new technology while minimizing additional requirements placed on employees. By effectively integrating the new technology with existing systems, organizations can streamline workflows, foster collaboration, and enhance operational efficiency, thereby laying a robust foundation for sustained success and growth in today's dynamic business landscape.

The final step in simplifying complexity revolves around facilitating the successful adoption of these new technologies and processes (i.e., manufacturing process automation and eQMS). Employing a robust change management methodology offers a systematic approach to assisting individuals in embracing the change. Key steps in effective change management include defining the change, when it will occur, who will be impacted, and what the associated risks and opportunities are. Finally, after defining these critical elements, you should develop and execute a comprehensive communication plan. This plan should delineate the message, channels, frequency, and communication responsibilities. Through carefully orchestrated change management efforts, organizations can ensure widespread acceptance and implementation of new and enhanced processes, along with any accompanying software, thereby maximizing the benefits derived from technological advancements.


In the contemporary landscape of challenging and chaotic work environments, simplicity emerges as a crucial asset. Achieving this requires the strategic incorporation of innovative technologies tailored to support meticulously designed, streamlined, and well-maintained business processes. Following a deliberate approach effectively prioritizes resources and allows organizations to direct time and energy toward the most critical activities.

Ryan Coughlin headshot

Ryan Coughlin is the vice president at Enterey Life Science Consulting and is responsible for developing and implementing corporate strategy as well as ensuring staff integration in accordance with strategic objectives.  Ryan has been with Enterey for over 11 years and has delivered on a large number of projects with multiple global biotech and pharmaceutical companies.

Prior to consulting, Ryan spent 22 years as an infantry officer in the United States Marine Corps, completing nine deployments to include one in Afghanistan and two in Iraq.  Ryan also served as a strategic planner with U.S. Central Command, and he finished his career as the operations officer for the 13th Marine Expeditionary Unit.

Ryan holds a Bachelor of Science degree from the United States Naval Academy and a master’s degree in international management from the University of Maryland, University College.

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