The notion that Pharma customers are looking for a “transcendental” experience as they integrate new IT functionality and capacity is echoed by Thermo Fisher Scientific’s Trish Meek, director of strategy – Informatics: “Our customers today are looking at how informatics can go beyond driving their processes to really transform their business,” says Meek. “To push the boundaries of innovation, [companies] are monitoring their performance and quality and actively looking for opportunities they can capitalize on to improve their operations.” This is due, in part, says Meek, to macro-trends like big data and predictive analytics that are changing IT across all industries. “Gone are the days where we rely on statistics to take a sample of data that is believed to represent the whole because analysis of the entire data set is impossible. Today’s modern in-memory computing platforms offer organizations the ability to look at their complete operation in real time or near real time.” Customers, explains Meek, want to achieve a higher level of quality and efficiency and business agility, but that often isn’t possible if that data is siloed and inaccessible. “Our customers are working with us to achieve a connected informatics infrastructure so that they can achieve these higher-level organizational goals.”
Citing the recent report, “Product Innovation Requires Laboratory Informatics Systems to Transcend Phases,” Meek notes that Gartner analyst Michael Shanler recommends manufacturers “prioritize end-to-end informatics investments and align metrics for innovation, domain expertise, operational efficiencies and quality.” “His recommendation,” explains Meek, “is based on an observation that today’s laboratories ‘are, for the most part, disconnected.’ By tightly integrating LIMS to other enterprise operation systems such as ERP, insights from the lab have the potential to be even more central to businesses seeking true enterprise-wide agility.” Businesses aren’t simply capturing and collecting data, Meek contends, they are making data actionable across the enterprise, putting management in the position to transform their businesses into agile organizations capable of responding quickly to market trends or new regulations and flexible enough to recognize and capitalize on cost-saving or margin-growing opportunities in the future.
Gene Tetreault, BIOVIA’s senior director of enterprise laboratory management, also knows that besides test and development related data, informatics are key to managing lab operations effectively and holistically. BIOVIA’s customers, says Tetreault, are seeking “a really good capability to manage inventories and managing all of the material flow in and out of the lab, as well as specialized things like environmental monitoring. That’s a manufacturing application typically included in the LIMs, but it’s all about managing the [potential for] microbial contamination in manufacturing. At the end of the day, people are looking for solutions to eliminate paper, to become more compliant, and to increase efficiencies in and around their labs. Once you get all of those systems [on a common electronic technology] platform, people are asking: ‘How do I connect other systems together? How do I get the data out of them?’” Tetreault explains that once a comprehensive lab informatics system is in place, discoverable information becomes available and lab operations managers have tremendous opportunity to gather and aggregate data and then use it to look forward operationally — creating models and other visualizations to support quality regimes in manufacturing.
GAPS TO CLOSE
Indeed, priorities have to be ordered and pursued to close the gaps created by the complexities of Pharma manufacturing environments and their supply chains. Business leader Brian Vogel, for Rockwell Automation’s Global Life Sciences business segment, finds Pharma needs to continue its efforts to organize IT to serve the enterprise holistically. “IT Infrastructure is a catch-all bucket that can include information and manufacturing software as well as hardware,” says Vogel. “Most Life Science manufacturers are moving in two key areas. Beyond acquisition, there is a major movement to shift capacity to more profitable locations. This is paralleled with an emphasis on consolidating IT-related systems while improving and expanding access to shop-floor information.”
As this unfolds, notes Vogel, Life Science manufacturers are coming to the realization that, while ERP is absolutely fundamental to driving the back end, there are considerable gaps at the shop floor. “As such, MES are now being deployed in the context of an enterprise solution. Rockwell Automation has a global customer base, so we see a wide variety of approaches to addressing this. Developing a common MES core to enforce quality, compliance and standard execution across all areas of manufacturing irrespective of what type or where a product is being manufactured is the leading trend.”
There will still be areas of the world, says Vogel, where the cost of energy and personnel will drive an approach that is more centered on adding resources and lean processes. “However, most manufacturers are avoiding the “band-aid” approach and are working to develop a more systematic, global MES core deployment model.”
Inarguably, says Jennifer Goldsmith, VP, Vault R&D, Veeva Systems, one the most data-driven areas in life sciences is manufacturing, which demands the ability to share information and collaborate quickly. Goldsmith contends raw data often exists in multiple systems and file formats, making it difficult for people to access and use. As a result, the data is often recreated in a document or structured report format to provide context and enable effective consumption. Content management systems (CMS) have become the home for many of these documents, and these systems typically lack the capability to incorporate new data as they are updated.