How digital transformation can revamp product and process visibility
The life sciences industry is currently at a critical juncture in its digital transformation. A blend of various events, such as the global pandemic and technological advancements in digitised research and manufacturing, prompted companies to adopt digital initiatives.
To gain a competitive advantage, organisations are proactively overhauling their digital transformation strategies. It has become evident that traditional paper-based operations and fragmented data collection methods limit their ability to adapt and thrive in the constantly shifting market. The pandemic forced standard practices to change. The capacity to collect, aggregate, and analyse data is now crucial for achieving success, impacting both regulatory compliance and profitability.
Segmented data hinders information exchange
Existing data silos are problematic because research and development and engineering design data are challenging for process line manufacturing stakeholders to access. On the manufacturing lines, the numerous types of equipment are often maintained by entirely different teams of engineers. It becomes difficult, costly, and time-consuming in such environments to blend the data created across these various “islands”.
The data silos also make it complex to communicate evidence back to the regulators that a highly controlled production environment is being maintained. With vast quantities of data being generated from many isolated systems – such as research, production, and quality control − visibility of how that data impacts production efficiency and product quality is limited.
Enhance value with digital transformation-enabled data control
True digital transformation is about developing the capabilities of capturing, blending, and contextualising data. It then enables that data to be quickly accessed and used by multiple organisational stakeholders.
Building data ontology (the ability to discern the properties of the various pieces of data and the relationships between them), building a data hierarchy, and designing a data architecture based on a consistent set of rules and governance all help to maximise the business value of the data that daily operations generate.
Digitalisation facilitates accessibility
The ability to capture and analyse data should also extend to life sciences operations’ contracted manufacturing. For example, from a regulatory standpoint, questions that pertain to drug ingredients, where those ingredients were sourced, and when the drug was produced need to be quickly answered – even if the drug in question has been manufactured via third-party contractors.
The data must also be managed beyond just one plant within one geography. Enterprise-wide data must account for variations across multiple plants and global regions where regulatory statutes may differ.
Digital transformation initiatives
To achieve the goals of high visibility and flexible operations, life sciences firms have launched digital transformation initiatives designed to help drive faster and more accurate business decisions.
Below are several examples of areas where significant digital transformation-based improvements are taking place:
The life sciences industry places great importance on traceability for safety reasons, which is crucial to regulators and customers alike. To ensure that drugs are manufactured to the correct standard, pharmaceutical companies must guarantee replicable production standards regardless of location. Achieving this level of consistency requires clear visibility into laboratory and manufacturing operations, which can be facilitated by digitisation using digital services, artificial intelligence, and analysis software.
These tools provide real-time feedback and increase connectivity, making cybersecurity a critical factor in safeguarding digitised operations.
Preparing the workforce
During the COVID-19 vaccine rollout, major drug manufacturers adopted an emergency "all-hands-on-deck" work approach. While successful in the short term, this approach became unsustainable due to ongoing labour shortages.
To tackle this problem and equip new employees with the necessary information, cost-effective solutions like "digital twins" have emerged. These tools provide employees with guidance, making it possible to manage tasks effectively.
A digital twin is a virtual software model that analyses data and performs simulations to assess performance and identify areas where efficiency can be improved. By pairing both virtual and physical worlds, manufacturers can analyse data in real time and monitor systems, which helps prevent problems before they occur, reducing downtime and creating opportunities for improved efficiency.
In life sciences industries, new employees can be trained in augmented reality (AR) and virtual reality (VR) environments, allowing them to address potential issues without disrupting existing operations. These AR-VR tools can also be used in engineering and manufacturing environments to enhance design and production processes.
Mastering both product and process data results in improved output quality. In some instances, batch processes can be converted to continuous processes, which increases output delivery and boosts output volumes, leading to a reduction in waste and improving sustainability in business processes.
Consistent production of high-quality products leads to energy savings, which is critical in the production of more sustainable drugs. The increased operational flexibility also allows for the reuse of single-use materials, such as bioreactor processes that traditionally deployed disposable bags.
The perfect storm
The manufacturing industry has been disrupted by a range of unforeseen events, which have disrupted operations, but also presented a unique opportunity for businesses to enhance their efficiency and profitability.
Digital transformation offers a panacea for multiple areas of business and enables life sciences enterprises to adapt and evolve. By embracing new technologies, companies can significantly enhance their operational efficiency, productivity, and customer satisfaction, allowing them to gain an edge in this competitive landscape. Digital transformation can revolutionise the way business is conducted, unlocking a world of possibilities for the manufacturing industry.