ROI: The strong case for EMI Software

By Robert Di Scipio, President and CEO, Aegis Analytical Corp.

In the 1980s, pharmaceutical company managers operated under the dictate: “Don’t screw up, and don’t run out of products.” In the 1990s, it changed to: “Look at deviations more closely to improve compliance.” Today, the mandate has evolved to: “Be more efficient.” Today’s emphasis on efficiency has motivated manufacturing companies to search for new tools to help reduce process variability and increase predictability. More often, their search leads successfully to Enterprise Manufacturing Intelligence (EMI).

EMI or MI (Manufacturing Intelligence) is a term that describes software used to compile a company's manufacturing data from disparate sources for purposes of reporting, analyzing and distributing data among enterprise-level and plant-floor systems. The main objective is to turn large amounts of disparate manufacturing data into usable, actionable knowledge, which in turn is used to produce favorable business results.

AMR Research identifies five functions that are vital to every EMI application:

1. Aggregation: Making data available from many disparate sources, most often databases.
2. Contextualization: Providing a structure or model for data to help users find what they need, usually in a folder tree utilizing a hierarchy such as the ISA-95 standard.
3. Analysis: Enabling users to analyze data across sources and production sites, including the ability for true ad hoc reporting.
4. Visualization: Providing tools to create visual summaries of the data to alert decision makers and highlight the most important information of the moment. The most common visualization tool is a dashboard.
5. Propagation: Automating the transfer of data from the plant-floor to enterprise-level systems such as SAP, or vice versa.

The Payback

Understanding the features and benefits of EMI software is not enough; the remaining challenge for manufacturing and process development teams is: "How to communicate to management that the efficiencies gained from EMI software translate to tangible ROI?"

To answer that question, Aegis, a provider of EMI solutions that help process manufacturers access, aggregate, contextualize and analyze data on-demand,  hosted a workshop at its Q4 2009 Discover Customer Conference that focused on how teams can "sell" the value of EMI software within their organizations. Conference representatives from more than 10 companies developed the following recommendations to help make the business case for EMI:

• Reducing the effort on data access frees up more time for analysis which can lead to yield and quality improvements.
• Document the time saved for regulatory submissions and reports.
• Use examples to demonstrate the value of context; as data on its own is meaningless.
• Don't overstate cost savings; inaccurate numbers can distract from the bigger picture.
• If the cost of analysis (a.k.a. time) is greatly reduced, more hypotheses can be tested.
• Provide numbers for the capital cost of full-time-equivalents (FTEs) vs. the operational cost of changing their roles to make them more effective.
• Document and share with industry colleagues the best practices for obtaining and using data from various source systems.
• Research and publish the value of EMI in other industries.
• Share industry articles that feature ROI and business benefits.

Case Study

The industry group discussed a common example of the pay-back from EMI software used to improve process performance.

Problem

Pharmaceutical companies are often faced with decisions as to how to best meet rising demand despite physical constraints on production. While increasing physical plant capacity and outsourcing are always options, they take time and capital, and involve technology transfer risk. Many companies are concentrating their efforts on process improvements, which have transferable benefits across the enterprise.

Solution

Several companies have used EMI software to support a Design of Experiments (DOE) project to identify cause/effect relationships between yield and input variables. The DOE team identifies the significant process variables that can have a positive impact on yield and also identifies new, valid operating ranges for these process variables which can drive yield increases. It deploys the software to validate process repeatability and to monitor that the process maintains the new state of control.

ROI

With a five percent increase in production achieved through enhancements to an existing process, many sites are able to realize tens of millions of dollars in savings, as well as the following benefits:

• Staffs have more time to work on other high-value activities.
• Self-service data access for manufacturing users means fewer demands on IT staff, which are free to work on other projects.
• Reduced process variability enables reduced inventory that is typically stock-piled to avoid stock outs.
• Improved supply chain predictability and reliability.
• Better understanding of process parameter relationships reduces the number of regulatory investigations and saves time for regulatory responses.
• Improved technology transfer and accelerated scale-up speeds time-to-market for new products.
• Improved collaboration with colleagues at other sites facing similar challenges.
• Better process understanding reduces potential batch failures.

Understanding how EMI software creates efficiencies across manufacturing, process development and IT is critical to helping management embrace its adoption.