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Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
The pharmaceutical industry faces complex issues in its effort to meet the requirements of the US Drug Supply Chain Security Act (DSCSA) (1). Pilot programs are needed to determine the feasibility of solutions, but the number of pilots required will be costly, in terms of money, time, and human resources. Virtual pilots, which use computer software to project or simulate physical pilots, can reduce this burden by providing some measure of learning or proof that a particular set of solutions would be scalable and workable.
Traditionally, databases, spreadsheets, dashboards, and test systems are used to understand systems, processes, and information and to predict the expected outcome of a physical pilot. Simulation software, however, is a more efficient technique that can be used to create and execute a virtual pilot for any process, including implementing the DSCSA in the pharmaceutical supply chain.
Simulation software has traditionally been used in manufacturing environments to replicate complex processes and provide a way to compare variations on specific scenarios to gain insights beyond algorithmic calculations found in spreadsheets. Due to the increase in computing power, simulation software has become easier to use and is increasingly seen in many industries. Simulation software is used to study processes within and between systems, departments, companies, and industries, including flow of products, people, cash, and information. Simulations can also address human behavior, time considerations, and the physical environment.
The software has matured to the point that it can be used during the information collection phase of a process study; it can provide meaningful results, both at a summary level and in the details and nuances of a process. Simulations can be used to create multiple scenarios to examine alternatives before large amounts of resources are expended to plan, develop, and execute a physical pilot. In fact, the virtual pilot can become the blueprint for the physical pilot.
Considering space and time constraints
Certain trading partners have physical space or time constraints that must be considered while implementing DSCSA requirements. Production lines, for example, vary in terms of space available to include serialization equipment. Simulation can provide insight into how best to use existing space, such as whether to serialize on the production line or serialize label-stock prior to the production run. Because case and pallet packing may be accomplished elsewhere in the facility, a simulation of the environment could help address product and staff flow.
Likewise, wholesalers may have time constraints in their window of operations for picking and packing orders to be delivered the next day. Timing and positioning of product and staff can be simulated to give projections of what to expect upon scale-up.
In addition to product and staff flow, information flow is crucial to meeting DSCSA requirements. Creating, supplying, and archiving DSCSA data can be simulated in order to gain experience with the latency, scalability, and feasibility of making data available from other systems within the organization. All of these flows can be studied in one simulation, to gain better insight on how they interact with each other and depend on each other. For example, the DSCSA law sets requirements for the timing of transaction information. A virtual pilot may be created to examine the process flow of information, product, and staff, should if the product arrives prior to the required Transaction Information, Transaction History, and Transaction Statement.
Another potential problem is that during the transition to 100% serialized products, companies in the supply chain may receive some serialized product and some non-serialized product. To better understand the transition, simulation techniques could examine varying numbers of products received, the mix or percentage of serialized vs non-serialized products on hand, and daily variability of serialized product and associated traceability data. Simulations can also examine the latency of delivery and number of suppliers.
Assessing human factors
For complex systems or processes, it’s often difficult to assess the impact of individual tasks or even understand these tasks and their variation throughout the workweek with enough clarity to confidently declare that a pilot and ensuing implementation will be successful. Operations under the various stages of DSCSA will require supplier, customer, and internal process changes as new steps are added to existing processes, such as receiving, picking, packing, and shipping. A virtual pilot could demonstrate how these new processes will affect daily tasks as well as identify what changes to support systems must be made. Simulations could also provide insight as to the activity balance needed to keep up with throughput of product and information.
A study of process and information will include interviewing or speaking to the people that perform the process. It is imperative that they are actively engaged in the information collection and analysis process. There are often nuances of why a particular step occurs and opportunities to explore with the process expert how newly accessible information, equipment, or adjacent processes might improve their process. Some of this information may be difficult to analyze. Using a virtual pilot, however, allows inclusion of behaviors, preferences, and other information points that can directly affect the outcome of the study or pilot. Also, the process expert often is drawn into the simulation process because it is interactive and easily understood. The end result is a more robust picture of the process under study that can be viewed at many levels and replicated with different scenarios (e.g., five people performing a task instead of four). Lastly, simulations can take into consideration the physical environment itself, such as the layout of equipment and materials, size of rooms, and distance between process points.
Incorporating business changes
Businesses are incorporating DSCSA-triggered changes into established operations that are constantly changing due to changes in business practices and economic conditions (e.g., new customers, the loss of existing customers, or acquisitions and divestitures). Virtual pilots based on simulations are an economic way of re-running DSCSA scenarios, given an ever-changing business environment. Adding a newly acquired warehouse or system to the simulation, for example, offers an opportunity to take advantage of existing work and test it against the new reality.
Unlike a static diagram, a simulated environment actually runs; processes require certain input, and if that input is not there, the process simulation stops until that problem is fixed. Each glitch that is fixed in the simulated environment is a glitch that won’t have to be fixed in the final physical pilot, during implementation, or in production.
Not every pilot requires an enormous investment in time, staff, or funds. A pilot may merely demonstrate proof-of-concept or experiment with connecting systems to those of trading partners in a test environment. A company may be interested in piloting what to do with all the new traceability data made possible due to the DSCSA law. A simulation or virtual pilot is capable of generating a lot of data and regenerating it based on changes in input parameters.
Implementing the DSCSA, with its serialized traceability system that is interoperable with thousands of trading partners, is a complex challenge. There are many issues yet to be understood and many details that need to be incorporated into a company’s plans and investment. There are also many benefits and opportunities to be gained by early adopters who realize the value that a more connected and visible supply chain brings. Virtual pilots, with simulation at their core, allow for better contingency planning, “what if” analysis, and even training of staff in developing an awareness of new departmental dependencies and contributions toward the new reality that serialization brings.
1. R. Celeste, “Global Serialization: Could Virtual Pilots Be in Our Future?,” >www.pharmtech.com/global-serialization-could-virtual-pilots-be-our-future, accessed Oct. 12, 2015.
About the Author
Robert Celeste is a founding partner of RC Partners healthcare consultancy and a former senior director at GS1 US, firstname.lastname@example.org.
Article DetailsBioPharm International
Vol. 28, No. 11
When referring to this article, please cite it as R. Celeste, "Piloting Track-and-Trace Implementation," BioPharm International 28 (11) 2015.