iSpeak Blog

Digital Transformation: Control, Prediction, and Optimization

Lisa J. Graham, PhD, PE
Robert K. Dillman
Thomas Carganico
Robert E. Perks, MSc, CEng
Digital Transformation: Control, Prediction, and Optimization

Digital transformation is the novel use of digital technology, including instrumentation and control systems, to solve traditional problems in a transformative manner. These digital solutions enable inherently new types of innovation and creativity, rather than simply enhancing, and supporting traditional methods.

By comparing process-related trends like efficiency, productivity, utilization, cost avoidance, and many other factors across sites, a benefit of digital transformation is leveraging new tools and a technology-empowered workforce to improve capital allocation and determine where to invest in new equipment and products.

Ultimately, building a workforce that is enabled by technology will allow process manufacturers to realize significant return on investment from their digital transformation strategies. By focusing on their employees and empowering them with innovative software, pharmaceutical companies can give their teams the tools they need to connect, grow, and pivot. Digital transformation must ensure that subject matter experts are positioned to gain insights from across data sources so that they can pivot quickly, making data-based decisions in time to improve batch or process outcomes.

Driven by the pandemic, digital adoption has taken a quantum leap from an organizational and an industrial point of view. This is why nowadays it plays a strategic role across companies at all levels to prevent repeated missteps, guiding product development and fast decision-making. Predictive software solutions are increasingly proving efficiency along with paperless solutions and automation systems, helping organizations in optimizing budgets, tools, and resource allocation.

With today’s available technology, pharmaceutical companies can provide their employees with the tools they need to increase quantity and value of production, reduce unexpected downtime, and drive sustainability improvements – even if they work remotely. In prior work models, employees were co-located or in cubicles every day of the week, even when doing independent work. With today’s plethora of communications software—including Slack, email, Atlassian, Zoom, Teams, Google Docs, and more—co-location is no longer the only way to drive collaboration. To take full advantage of available solutions, companies should consider building remote-first work environments, with in-person options when needed, while enhancing employees’ digital skills with software that encourages collaboration across the organization.

The Digital Transformation Content Area during the 2022 ISPE Annual Meeting & Expo will explore multiple aspects of the digital transformation journey from initial concept through to successful realization and implementation.

This year’s topics address both the challenges and solutions afforded by digital technologies in the areas of development, commercialization, manufacturing, and quality.

One of our keynotes at this year’s event will be provided Andres Angelini, CEO of SoftVision. Andres will present his experiences working with a number of diverse companies and industries to develop not only a transformative vision but also to implement that vison in order to realize successful outcomes.

Amongst the topics being presented are:

Pharma 4.0™: The session will provide an overview of the status of the pharmaceutical industry as it moves further into the digital realm.

Digitalization opens new horizons to achieve new levels of connectivity, transparency, agility, and productivity through the application of faster and more accurate information to (automated) decision-making. In current production processes different data sets are created for each process. Visualizing the data sets amongst different process steps will automatically trigger missing data, misaligned data, or duplicate data. Moving to Pharma 4.0, each data set will need to be assessable at any time in any business layer. Therefore, a system needs to be in place to show the data architecture and how it interacts with various processes. This session will discuss the status and examples of practical methodologies to transition to a digitalized Phara 4.0 Operating Model-based organization.

The new GAMP® 5 Guide Second Edition: An overview and roundtable discussion.

The GAMP® 5 Guide – A Risk-Based Approach to Compliant GxP Computerized Systems was published in 2008 and is widely recognized as the leading practical guidance for the implementation, management, and operation of computerized GxP systems. Since the original publication date, technology has advanced and even though the principles and framework are as applicable today as they ever have been, the elapse of time since publication may give the impression that the content may not be current. This session will describe how, while maintaining the principles and framework of the First Edition, the publication of the GAMP® 5 Second Edition updates their application in the modern world. It highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate approaches. Presentations delivered in this session will provide a foundation for the "New GAMP® 5 2nd Edition roundtable" session to follow which will allow for a deeper dive into the revisions applied to the Second Edition. In addition, attendees will have the opportunity to engage in direct discussion with the primary authors of the material covering these topics.

Pharma 3.0 to 4.0: What is necessary to successfully move from Pharma 3.0 to a digitized facility and how to harness the power of the Pharma 4.0™ vision.

Data-oriented process maps specifically designed for the industry 4.0 environment, resulting in an analysis that provides input for the working plan describing how to reach the desired data integrated level, needed for the transformation towards Pharma 4.0™. Newer data analytics and artificial intelligence technologies are quickly becoming realistic tools to revolutionize how the industry distills new value out of the rising sea of available data. Quality organizations will need to make strategic shifts in process, approach, skills, and mindset to redefine how data is used to sustainably and efficiently achieve the quality mission. Additionally, leading pharmaceutical companies are creating a digital ecosystem and aggressively adopting 4.0 technologies like Cloud, AI, machine learning and automation to gain the speed and scale they need.

Data Analytics: How the use of ever-increasing availability of data will enhance the understanding of complex processes in development and manufacturing.

This session will cover advanced data analytics techniques to discover insights on the manufacturing processes using applied advanced data analytics including statistical modeling and machine learning to predict when the yield will be low during the manufacturing process.

Data analysis and trending tools as they relate to the need to use the data collected for process control, investigation, and root cause analysis. More information from manufacturing processes needs mathematical models that provide flexibility and accuracy for complex system using Bayesian statistical methods,

Validation: The presentations will focus on the use of digital technologies in the validation environment to minimize errors and maximize efficiencies.

The terms “4.0” and “digital transformation” are generally understood to be technology focused. There are much deeper changes that must be made both in the tangible and intangible arenas, from documented processes such as validation to deeply rooted cultural shifts. This session will dive into how we need to shift thinking when it comes to the approaches taken with validation. We will also discuss the more important shift in our thinking: all these changes are not just to support an initiative with a finite beginning and end, but rather they should be part of a continuous modernization that supports getting regulated industries closer to where we are in our personal and consumer lives.

Digital Twins: The use of digital twins is becoming a necessity in today’s manufacturing environment. The presentation will demonstrate the use of a digital twin for efficient product life cycling.

Join us at the 2022 ISPE Annual Meeting & Expo to learn about all of this and more!

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