1. Knowledge-driven operations

It all begins with connectivity, which enables the seamless aggregation and integration of information generated by various operations, including machines, equipment, and personnel. This universal connectivity forms the foundation for all subsequent digital transformation initiatives. Establishing connectivity to Operational Technology (OT) equipment and systems doesn’t necessarily require revalidation. Through read-only connections, Life Sciences manufacturers can gain visibility into rich OT data without altering their control system. This provides valuable insights into performance and drives actionable improvements for future processes. Production control and information management systems play a vital role in digital transformation. They serve as the core components monitoring current operating conditions and managing workflows to maintain optimal throughput and quality standards. Integrating information from operations management systems into this layer enhances consistency and supports continuous improvement efforts. An integrated information enablement strategy enriches data with critical production context, facilitating future analytics projects.

Integration into the broader enterprise landscape enables facilities to adapt to market needs effectively. Enterprise systems like Enterprise Resource Planning (ERPs) provide valuable production planning context to systems like Manufacturing Operations Management (MOMs), enabling autonomous production planning and execution based on customer orders. Life Sciences organizations must transcend siloed facilities and establish an intelligent facility network. This network provides visibility into enterprise-level production, enabling dynamic scheduling across the network and reducing time to market and inventory costs.

Operational intelligence forms the backbone of digital transformation, enabling the transformation of operations data into actionable insights through industrial analytics. An interconnected architecture allows analytical models to be deployed anywhere from edge to cloud, facilitating process optimization by continuously modeling the impact of changes and identifying optimal actions. These prescriptive insights drive efficiency and productivity across operations.

Effective knowledge-driven operations require connecting insights to the right people and systems at the right time. Bi-directional data flow inherent in a well-designed intelligent architecture enables information-driven production control at the asset or facility level. Autonomous systems mitigate human error and deliver consistent results. Integrated Augmented Reality (AR) solutions empower operators with real-time alerts and prescriptive insights, leading to more informed decisions and efficient production processes.

Pfizer, a renowned pharmaceutical company, exemplifies the transformative power of digital initiatives in revolutionizing patient care. In 2019 alone, their digital initiatives enabled the production of 3 million additional doses of a critical product beyond the planned quantity in one facility. Pfizer Global Supply (PGS), operating across 42 global manufacturing sites, produces over 23 billion doses of medicine annually. Their strategic focus on leveraging digital technologies for drug discovery, enhancing patient experiences, and streamlining operations through automation showcases the impact of data-driven innovation in changing lives and accelerating the delivery of vital medicines to patients in need.

2. Enabling workforce optimization

Improving the employee experience across the facility is crucial for optimizing operations and ensuring efficient production processes. Validating changes to existing production lines can be a significant investment, but it may not be worth it if the resulting value for production is uncertain. However, with access to rich data from operations and digital twin simulations, engineers gain the capability to thoroughly investigate and verify the impact of process improvements before implementing any changes in the physical world. This functionality empowers engineers to confirm enhancements in quality and throughput, thereby reducing the risk associated with revalidation processes.

Access to real-time production data and prescriptive analytical insights in a single interface simplifies operations for employees. Equipped with role-based dashboard views and prescriptive guidance, connected workers can swiftly identify production issues and prevent losses before they occur. Moreover, digital work instructions visualized through Augmented Reality (AR) provide on-demand, hands-free guidance on the shop floor, effectively reducing process errors and accelerating issue resolution.

Keeping pace with increasingly complex equipment and maintenance procedures poses challenges for engineers, particularly those new to the role. However, with access to predictive insights and digital work instruction visualizations, engineers can achieve higher first-time fix rates and accelerate time to resolution. Enforceable workflows and automated record-keeping ensure that machine calibration and cleaning procedures are completed promptly and according to schedule, further enhancing operational efficiency.

3. Enhancing operations efficiency through digital tools

Digital recordkeeping serves as a pivotal tool in streamlining compliance processes and expediting batch release by simplifying the review process. Electronic batch records autonomously capture essential quality and compliance information throughout production, eliminating the need for manual intervention. This facilitates immediate access to accurate data and enables real-time review by exception only, obviating the necessity for the quality assurance team to delay batch reviews until completion.

Companies like Cytiva, a prominent player in the life sciences sector, are at the forefront of embracing digital manufacturing to drive enhanced productivity, safety, and patient outcomes. With a workforce spanning over 7,000 associates across 40 sites, Cytiva provides critical tools and services for various activities, ranging from fundamental biological research to the development of vaccines, biologic drugs, and novel cell and gene therapies. As part of their digital transformation and Industry 4.0 initiative, Cytiva aimed to establish a connected digital enterprise, streamlining internal operations and reducing time-to-market for end customers. Their Figurate automation platform, powered by Rockwell Automation’s PlantPAx^® system, integrates control and communication capabilities for both upstream and downstream processes. By harnessing data insights, standardized digital libraries, and automation, Cytiva expedites drug manufacturing, achieving economies of scale with flexibility and efficiency.

Navigating a global supply chain and adapting to disruptions have become standard practices in modern production planning. End-toend supply chain integration offers comprehensive visibility into raw material inventory, expiration dates, work in progress, and customer demand across the enterprise. These insights empower production planning managers to dynamically schedule production to meet market needs while minimizing operating costs.

As production and IT systems continue to converge and responsibilities become shared, streamlining IT/OT convergence becomes imperative. Interoperable IT and OT systems simplify and expedite the process of integrating new applications into the architecture. With various point solutions and major platforms offering differing stability and support, IT administrators can have confidence in their digital transformation architecture built on a platform that ensures longevity and recognized stability.

Eli Lilly and Company, a global healthcare leader, embarked on a transformative journey to enhance its manufacturing and quality operations. Their IT and OT organizations have collaboratively worked for over a decade, emphasizing the production of life-saving medicines with a commitment to “safety first and quality always.” In the early 2000s, incidents stemming from conflicts between IT and OT domains prompted strategic changes. The company transitioned process automation from engineering to IT, emphasizing shared governance. Presently, their robust partnership facilitates smarter production operations, leveraging IT/OT convergence. Eli Lilly’s dedication to collaboration has yielded substantial benefits, positioning them strongly in the digital era.

4. Conclusion

Companies that invest in an enterprise-wide transformation strategy built upon an intelligent architecture will be best equipped to adapt to shifts in the market and capitalize on tomorrow’s opportunities. Integrated technology provides access to the information needed to make decisions in real time and optimize operations in any situation.