The pharmaceutical industry is going through a significant change in manufacturing and supply chain management driven by emerging global government mandates for them to “serialize” their products. Each unit of product must have a unique ID that can be tracked through the full supply chain to the end user customer. This is to insure quality, to enable tracing, and also, to suppress the use of counterfeit drugs (estimated at 10% of the worlds’ drugs). The mandates have been coming out across the globe over the last few years. The US is on the verge of putting their “mandate” in place this year. (Click here to learn more about pharmaceutical product serialization.)
In this article I will look at how our customer, one of the top 10 pharmaceuticals, used CorasWorks to create a Program Management solution that is used to manage their $200M global product serialization manufacturing change program. I will also address how the process worked as this story is a great example of how customers are able to achieve breakthrough results without the risks, costs, and time delays that are common for most enterprise application projects.
This customer is a very large manufacturer of pharmaceuticals – one of the worlds largest. These mandates from around the world are requiring them to update all of their manufacturing lines to support the unique ID serialization requirements for each unit that is produced. Different mandates from different countries/regions also have different requirements. This process will cost our customer 200 million dollars over the next five years. They will need to upgrade more than 100 different manufacturing lines in 400 different projects around the world in more than 20 countries.
The objective of our customer was to be able to centrally manage the program across the globe. They had a strategic team in place to drive this initiative globally. They had very precise requirements such as:
- They needed top down management visibility and the ability to then drill down in details.
- They wanted to be able to see all of the projects by a) defined KPI’s for the b) defined stages of work.
- Their process requires that each local manager provide updates on each project each month.
- Most projects actually had two workstreams, so two different updates, for a total of 400 managers providing updating.
- They wanted the ability for comments for each update.
- These updates drive the KPI’s from the bottom, up the stack.
- There were very complex KPI roll-up calculations so that KPIs would cascade upward from the base project to the top of the Mandate, Geography, Country, Product, etc.
- The customer then wanted to be able to see where everything stood by different pivots such as by Mandate, by Country, by Product, by Workstream, by Line within in a real time, interactive interface.
The customer had detailed, application specific requirements for the Program Management system. Yet, time was short. Some projects were already under way, so they wanted the system relatively quickly targeting about 4 months. They had evaluated options of custom development however the cost, risk of delivery, and length of time to delivery deterred them from this option. They also looked at leveraging other owned Project Portfolio Management systems, however, they needed very precise features and in effect this made the use of these systems as risky as custom development.
So, the challenge was how to:
- get a Program Management system that met their very precise requirements
- in a relatively short time frame
- at the lowest cost possible and without “breaking the bank”
- with an acceptable level of risk of delivery
- that would support changes as the program evolved and lessons were learned
- and that was acceptable to IT today and supportable over the 5 years of the program.
This customer uses SharePoint 2010. In fact, they are in the Top 100 of SharePoint deployments supporting more than 80,000 users across four global regions. They have adopted an Enterprise Shared Services Environment (ESSE) model in which they have a common infrastructure that is shared across all global geographies, all business groups, and, all employees. They have three different farms (server environments) for different categories of work.
- The Enterprise Shared Services Environment for those applications that do not require any custom compiled code.
- A Custom Environment that allows custom code but is much more expensive to manage.
- A Regulated Environment that is certified for regulated processes and information such as Clinical Trials.
They have been a CorasWorks customer since 2004. The CorasWorks v11 Work Management Platform is part of the infrastructure on the Enterprise Shared Services Environment available to all 80,000+ users. The complex requirements of this Program Management application were more sophisticated than just about any other application running on ESSE. However, they believed that it might be possible to build and deploy it on ESSE. This would mean that it would have to be created without requiring custom coding, just leveraging the CorasWorks Work Management Advanced Configuration Tools. If it worked, it would also mean that they could meet all of the challenge criteria noted above.
Working with the customers’ Service Delivery Team for the manufacturing group (that delivers applications to that group on ESSE) we did a quick pilot to simulate the applications’ operating requirements in the ESSE environment. This was successful and the business customer decided to go with CorasWorks software and CorasWorks Professional Services to build the application on the ESSE environment.
This was a joint application development project. The Service Delivery Team had built other applications using CorasWorks within ESSE so they were familiar with the core capabilities of CorasWorks. They were able to work closely with CorasWorks on the design, the requirements, the testing, and changes. They also handled the interactions with the business group. The teams approach was an Agile methodology with the objective of having an early working solution in place, that would be built through sprints with user input. In sum, it was a highly collaborative project between CorasWorks, the customers’ Service Delivery Team, and the business user group.
The base application was deployed for initial testing within 60 days. The ability to quickly get the base application with a full information data set up and running was important for real time user input and changes. It went through a series of sprints for additional phases and changes. In addition, the application was re-factored three times in order to accommodate the changes and stay within the specified end user performance limits.
In sum, within 5 months the system went from development to enterprise production within the ESSE environment. Comparing the results to the challenge criteria stated above, the system was delivered:
- meeting the specified technical requirements and the ones that came up through ongoing changes
- almost within the time frame (it actually took an extra month to finish the project due to elapsed time delays with changes, user testing, and data loading) – but the project was still 2x faster than alternatives had been estimated
- within the specified budget – that was about half of the initial estimate for competitive alternatives
- the risk was mitigated by the known factor of CorasWorks capabilities on the ESSE environment
- the resulting system is fully supportable by the customers’ Service Delivery Team since it is built on the open standard CorasWorks platform
- and IT was already supporting ESSE and CorasWorks and will continue to support it as part of their global ESSE environment
My Wrap Up
This customer now has the capability to manage the global product serialization program. They are in a great position to work towards success. The program, an important one for them (remember counterfeiting is 10% of drugs), is also very important to the health and safety of all of us. By investing to put the proper, well specified, program management system in place to support their defined process they have decreased their risks and increased their probability of success because they are providing a lot more visibility which drives greater accountability for results.
The General Challenge. Most business-driven Program Management solutions are very custom. It is the nature of the beast. It is also a key to competitive differentiation. Your programs/initiatives tend to be your big value creating or risk reducing activities. But, it is very difficult and almost counter-productive for a vendor to try and build a general product for this purpose. There are some COTS Program Management systems, but, if you try to use them for a significant program like this one you’d have to basically rip them apart to deliver on a typical set of requirements. The unique flexibility of the CorasWorks Work Management platform makes it a very effective way to deliver on these custom Program Management applications. As shown in this example, effectively they used a COTS product (CorasWorks) on an existing enterprise shared services (ESSE) platform to create a very custom Program Management solution without requiring any new custom compiled code.