“Something as simple as a manufacturing specification may require manual update and confirmation of values as they change over time. Additionally, sharing this information across geographies and between organizations has also presented challenges. Cloud-based CMS allow easy, secure sharing of valuable information with other systems and a larger, relevant audience,” says Goldsmith. “Users effortlessly collaborate with one another, while all communication, content and versions are tracked and stored. As cloud-based CMS evolve, they will challenge traditional definitions of documents, enabling the storing and updating of structured data with unstructured content — such as descriptions — in one document.”
OPEX OR CAPEX?
When it comes to expensing operational necessities like an IT infrastructure, controlling that spend can be challenging, especially because it is so critical to operational excellence and an efficient, compliant production environment. With Pharma’s business models evolving quickly to meet the needs of the swiftly changing global marketplace, the industry is shifting how it invests and maintains its IT infrastructure. Some are looking for alternative ways to account for IT expenditures and shifting funding from the capital expense (CapEx) side of the balance sheet to the operating expense (OpEx) side in an attempt to better manage the rising and unavoidable cost of fielding a world-class IT infrastructure. When it comes to managing IT expenses, each company may take an approach biased in one direction or another depending on individual preferences and financial exigencies, but there’s no clear “right” answer and Rockwell’s Vogel agrees. “There is no right or wrong answer here; manufacturers of all sizes are managing expenditures as operating expenses and/or capital expenses at both the corporate and site levels,” observes Vogel. “Though most customers/partners who are developing the core model are treating the upfront design and build as a capital expense, and classifying the funding of the local extensions and roll-out as an operational expense.”
Werum’s Blumenthal offers this insight: “There is a trend on the radar that customers are expecting realistic solutions beyond the cloud technology discussion in the IT world. A new idea is to use a supplier-hosted MES and pay per batch record instead of purchasing complex IT infrastructure and an MES system.” That is an interesting proposition and may offer very lean organizations an opportunity to stick to core competencies and leave the heavy lifting to companies whose core competency is in fact IT operations.
Speaking of heavy lifting, Veeva’s Goldsmith points out that the emergence of cloud applications has provided a new alternative for financing projects, moving IT infrastructure spend away from capital expenditures and toward operating expenses. “New projects typically require a significant amount of upfront capital, and if the investment needed is too high, it may deter organizations from pursuing these opportunities at all,” says Goldsmith. “The cloud lowers the barrier to entry and supports a pay-as-you-go model, enabling companies to try new ideas without long-term commitment and easily scale as projects grow.”
BIOVIA’s Tetreault says that customers usually don’t include the company in the nitty-gritty of how they choose to fund IT investments, but that when making IT-related capital purchases, “cost of ownership and time to value are two key metrics,” that help customers valuate the potential return of their IT investment. “We are trying to deliver software at the lowest cost. We’re trying to make it so they can basically get value [even if] it is from one mapped out goal. Cloud solutions, certificates of valuation, etc., all sorts of things to deliver tangible value and to lower both of those numbers. That opens up the world tremendously to thousands of labs, as opposed to hundreds of labs.”
It’s generally accepted that contemporary IT and informatics solutions must be adopted to effectively and profitably manage Pharma’s operations or face the consequences. But just how are drug manufacturers working with vendors and integrators to apply and implement such necessary technologies? Rockwell’s Vogel offers this insight: “A hybrid-regulated consumer goods manufacturer with over 100K SKUs needed to increase production throughput by 20 percent (without increasing personnel), and needed to meet increased market demand. After reviewing its manufacturing process, it was determined that the “First Time Pass” had to increase and the “Quality Hold Time” had to decrease by more than 60 percent. More work orders per shift also needed to be executed to meet the company’s goals. After implementing a new MES solution, the number of work orders per shift doubled, First Time Pass increased by 85 percent, and quality hold decreased by more than 90 percent. Now, adoption of the solution is underway in four additional plants.”
Another of Rockwell’s customers, a global life sciences manufacturer was rolling out an ERP system to all its manufacturing facilities, Vogel says, explaining that the company needed to standardize its manufacturing intelligence interface with ERP and replace the myriad of existing MES site-level systems with an enterprise-wide solution. “The first challenge was the time frame, and the second was ensuring the MES system met existing functional and regulatory needs at each site — regardless of what or how a product or ingredient was being made. The system was rolled out in stages, focusing on core areas one at a time. Now, 17 plants are live, and five will go live in roughly 30 months since the program started.” While each customer had different business drivers, says Vogel, the need to standardize their manufacturing process and improve time-to-results was achieved through Rockwell’s platform.