Case Study: Charles Laboratories, Allergy Products Division

Many of the questions at the end of the chapter are based on the following case study. Feel free to skip to the main chapter text and then return to the case study when you work through the practice questions at the end of the chapter.

Background

Charles Laboratories has been a successful pharmaceutical company for more than 60 years. Originally family owned, it is now a public company with more than 40 different medicines and healthcare products in the marketplace. New drugs are constantly being researched and subjected to clinical trials, which are highly regulated by the Food and Drug Administration (FDA).

Problem Statement

One division of Charles Laboratories, the one assigned to discover new allergy medications, wants to implement a new solution for managing inventory of the raw ingredients that make up the products in clinical trials. Some of the ingredients are strictly controlled, as they are potent and highly sought after in the illegal drug market. Security and accuracy are key to any application at Charles.

The Allergy Products division, which has typically focused on only two products in the marketplace, has always used manual ledgers to track the raw materials inventory, but a recent increase in the number of new drugs in clinical trials has made an automated solution more desirable. This increase in the number of products being proposed will also result in a tripling of the current staff.

Current System

The current system is not automated. Although there is a very tightly defined process, there is no software support.

The parent company is providing a team of six experienced Visual Basic programmers to build the solution. They have not worked together before, but they are all long-term employees of Charles and know the pharmaceutical business well.

Division Manager

"I have been here for more than 10 years. In all that time, we have been very successful with our two flagship products. Now the company has asked us to push six new products through clinical trials in the next three years. We negotiated a four-month delay so that we could get our staff and our systems prepared."

Lab MIS Manager

"I will be managing the team we have selected. All six of the developers involved attended the same .NET class (two weeks) together and got to know each other a bit there. I worry a little about Perry. He has a reputation as a "cowboy." Also, the aggressive deadline might make some of the others think about cutting corners. I can't have that.

We do have one clear advantage. Our primary architect, not one of the six developers, is Geza. He has a lot of experience and success with .NET. I just hope he can pass that on to the others.

All together, we plan to spend half a million dollars on this project. We also hope that whatever they build can be supported by my own staff once it's fully completed."

Inventory Manager

"It has always been just Donna and me in here. Now they tell me there will be three more inventory clerks and about 20 more lab technicians making requests. We have to measure chemicals out of these huge 25- or 50-kilogram drums and keep inventory levels accurate to within a gram."

Envisioned System

The envisioned system is fairly simple. Lab technicians, all located in the same building, make requests through the system. The inventory clerks measure out the requested materials into separate containers (in sterile booths), deliver materials to the lab, and subtract the dispensed chemicals from the current inventory. A daily "low inventory" report is a simple, threshold-driven way to keep from running out of needed materials.

Division Manager

"We want to keep the design simple, but we plan follow-up releases to add new features. For example, automated reordering is too much for the first release, but we would like to do it eventually. By automating this process, we hope to save $250,000 annually in personnel costs over the term of this big clinical push."

Lab MIS Manager

"Any system we put in place must be flawless. It's not quite like the quality required for a space shuttle, for example, but it's close. The FDA has strict guidelines around clinical trials. Each facet of our application must be validated and tested to the nth degree."

Lab Technician

"This is great. The request forms we currently use are time-consuming. We've been told that current inventory levels and a list of chemicals carried in inventory will be listed for us. We just click and go. No more guesses about whether we have enough magnesium sulfate for a trial."