Thermo Fisher Scientific’s Meek notes that with her company’s customer base, companies often take two distinct approaches: The first, one-stop shopping and the second, integrated laboratory systems. “Which approach makes the most sense is largely based on the existing systems investment and processes that are implemented in those systems,” says Meek. “One major pharmaceutical manufacturer has implemented a global deployment of our LIMS and it is fully integrated with external LES and SDMS. By focusing on strong integration between these applications, they feel that they have optimized their deployment and have a continuous flow of information enabling them to make real-time decisions. They are currently looking at predictive analytics tools to drive to a more proactive environment.”
Customers who have not made a significant investment in LES and SDMS capabilities already, says Meek, see the value in a single solution that provides the functionality of a LIMS, LES and SDMS in one. “The customer was looking at Lab Execution and LIMS and when they realized that they could get both in a single solution, it made their decision for them. Their comment was that, ‘We never thought we would find a solution for lab execution and management that is so tightly integrated, why would we go with anything else?’”
Veeva’s Goldsmith notes good documentation is essential for manufacturing facilities to ensure activities are executed correctly and are in compliance. Most companies, she says, rely on content management systems that were built when companies were less impacted by globalization and had fewer regulatory requirements. “Today, customers are looking for solutions that enable greater visibility and flexibility, and collaboration across all parties. We have customers that are in the early stages of adoption, having built a single source of truth for SOPs accessible by both document originators and consumers. Giving more parties visibility into document status accelerates edit, review and approval cycles. Built-in read and understood tasks also allow for real-time tracking of new SOPs as they are rolled out across departments and sites.”
Goldsmith explains that her company’s more mature customers understand that such systems deliver powerful insights into the health of processes, departments and partnerships. “Most metrics monitor output, only measuring what has happened. Tracking upstream metrics, by contrast, provides leading indicators into potential problems and can help identify bottlenecks before the damage is done,” says Goldsmith. Companies that have developed a deeper understanding of their business processes are using metrics to gauge performance across the organization, and drive continuous process improvements and proactive decision-making.
Werum’s Blumenthal provides a closer look outlining two solutions delivered to customers using their popular platform. “A customer is using our [platform] in process development to develop a stable, best-fitting process for solid dosage products,” says Blumenthal. “The main business goal is to be faster to market with a new product. By using MES features like MBR and EBR for creating recipes and evaluating best fitting parameters via Design of Experiments, new processes will be continuously improved and stabilized. Development with such tools and the transfer of the gained knowledge to the next production phase is much faster and is the enabler to achieve expected business goals.”
Another Werum customer is using the company’s technologies in the commercial production of a biopharmaceutical product. The main business goal is to increase the yield of the factory, says Blumenthal. “Since production runs are very long, it is critical that the process is stable without any contamination. This can be achieved through our [platform] by controlling all process steps with additional checks of all material and all equipment that is used.” Both business goals, he says, can be supported by the same system. The complete functionality supported by Werum’s platform, says Blumenthal, is defined and controlled via recipes. The creation and change of recipes (MBRs) can be both flexible (process development) or highly controlled with access rights (commercial manufacturing).
A PATH TO IMPROVED OPERATIONS
“Many more parties are involved in the end-to-end production of a product adding another layer of complexity to the development process,” explains Goldsmith. Supporting technologies are often deployed in a siloed model, limiting the ability for parties to collaborate directly, thus forcing the use of uncontrolled communication mechanisms, such as email, she says. “Mature companies are taking a strategic approach to technology, creating a strong foundation for information sharing and collaboration to achieve the biggest benefit. Companies that succeed in sharing information with all parties involved and between systems see significant improvements in all five areas.”
Werum’s approach, says Blumenthal, “is the implementation of a recipe-driven system that leads the operator through the business processes, enforcing the ‘right first-time’ principle and compliance with all pharma regulations. “Creating best practice recipes and following the guidance of the system along such recipes (like a navigation system) will always result in best product quality, reduced costs, safety, reduced risks and compliance,” Blumenthal says.
Tetreault agrees that LES enforces right first time: “When you’re following the process and doing QC testing on a particular batch — step one, prepare the agents and global phase samples and so forth. Step two, do this. Step three, do that. On step one, if you don’t adhere to the process of running that analytical test, if you don’t adhere to all the equipment being calibrated, all the materials being within tolerance and of course not expired, all of the training records — [the LES is] enforcing all of that at the time that you’re doing the test.” Tetreault notes test regimes, independent of the quality control provided by an integrated lab informatics platform can be problematic because any issues or mistakes may only be revealed after a review “… somebody comes along and reviews it and find that there’s a problem. Now there’s a day’s worth of effort into doing something that was wrong on the first step.” Tetreault explains BIOVIA’s platform (as with others) electronically enforce process rubrics at the time they are being done. “It reduces costs. It increases quality. It decreases safety risk.”