Digital transformation is revolutionizing pharmaceutical research and manufacturing. Driven by technologies such as advanced automation, smart sensors, artificial intelligence and machine learning, digital transformation provides new opportunities for organizations to streamline workflows, boost productivity and improve quality throughout the value chain.
From faster decision-making through to more flexible and efficient ways of working, many of the opportunities that come from digital transformation stem from seamless and secure sharing of information between teams and technologies, across multiple sites and organizations, in real time. However, a lack of standardization, in terms of both data and processes, has made leveraging these gains more challenging. Now, pharmaceutical industry stakeholders, including technology vendors, are taking the lead to facilitate change.
Eliminating data silos through seamless data standardization
Data standardization has long been a challenge for pharmaceutical companies, resulting from a historic lack of standardized data formats used across the informatics industry.
The vast majority of pharmaceutical workflows utilize instruments and digital technologies from multiple vendors. Poor interoperability between traditional software applications has meant laboratories must typically use separate, vendor-specific systems to store, manage and analyze data generated by different instrument fleets. This situation creates impenetrable ‘data silos’ that increase the administrative burden for users, reduce organizational efficiency and potentially compromise data integrity due to the need for transcription and validation steps.
An industry-wide commitment to open data standards is key to fulfilling the promise of digital transformation. To meet this need, vendor independent standards are now emerging based on these open data standards, the latest informatics solutions support broad instrument control, allowing, for example, laboratories to manage their whole fleet of instruments regardless of vendor, using a single integrated system. Improved interoperability also eliminates the need for time-consuming transcription and validation steps, safeguarding the accuracy and completeness of data across workflows. These solutions are helping organizations work more efficiently, improving data integrity and providing a strong foundation for future digitalization efforts.
Improving pharmaceutical process standardization
Process standardization will also play a key role in enabling digital transformation. Pharmaceutical value chains comprise complex networks of interconnected stakeholders. Data must be shared by teams from research through to manufacturing and distribution, not only within an organization, but often with other external partners.
However, many of the solutions currently used by teams to collect, manage and share pharmaceutical data are heterogeneous, with different architectures, user interfaces and performance capabilities. While the use of differing systems can arise for multiple reasons – mergers and acquisitions, rapid business growth, or the implementation of point-based solutions, for example – ultimately, the outcomes are the same. Inconsistent data management approaches are inherently inefficient and proving increasingly challenging from a user experience standpoint as datasets grow larger and become more complex.
As data integrity principles expand upstream from formerly unregulated aspects of the drug development journey, poor process standardization also puts compliance at risk. Today, regulatory inspectors may, for instance, request documented evidence for why a decision to pursue one drug candidate was selected over another, despite this decision being taken long before any good laboratory practice (GLP) regulations formally apply.
Such situations emphasize the need for traceability and data security across the full length of the pharmaceutical value chain. When data and audit trails are accessed using poorly integrated software systems supporting heterogeneous interfaces, demonstrating compliance is made more challenging – increasing the time, administrative burden and, indeed, stress of providing documentary evidence. It’s clear the industry needs more efficient and effective informatics solutions.
Integrated laboratory informatics: The key to enhanced standardization
With digital transformation critical for maintaining a scientific and commercial competitive advantage, vendors increasingly recognize the challenges presented by poor data and process standardization, and are developing informatics solutions to streamline data management and support seamless workflow integration.
Integrated laboratory informatics solutions that provide a consistent user experience from early research through to manufacturing are key to improving standardization within the pharmaceutical industry. These transformative solutions eliminate silos by bringing data together in a single integrated ecosystem, enabling, for example, the frictionless transfer of analytical methods from research to manufacturing, or the analysis of workflow data regardless of vendor technology.
Such systems help teams work faster and more efficiently by avoiding the need to use multiple user interfaces, improving cost-efficiency by reducing the resources companies must allocate to training. Using a single system to access end-to-end workflows also improves traceability, enabling data and audit trails to be easily searched to help organizations demonstrate and maintain compliance with regulatory requirements.
With data accessibility and transferability key to maximizing the benefits of digital transformation, some vendors are taking the lead, developing laboratory informatics solutions to support improved standardization of data and processes across the pharmaceutical value chain. By implementing better integrated solutions, organizations can overcome fragmented working practices to achieve a more efficient, productive and innovative pharmaceutical industry.