Focus First on Business Operations and ROI and Second on "Going Paperless"

We talk a good deal about “the paperless lab,” but how do real labs become “paperless”? This article highlights two different laboratory software projects that illustrate the tasks and issues that came up based on specific projects and situations. The idea is to help you think about your own situation if you’re considering moving toward a paperless lab. These examples are given by two members of the upcoming LRIG (Laboratory Robotics Interest Group) and LIMS (Laboratory Information Management System)/Laboratory Informatics ELN (Electronic Laboratory Notebook) expert panel being held in Boston, Massachusetts, on February 10, 2010, where these examples will be more fully explored.

QC (Quality Control) Project: Major Pharmaceutical

This example comes from a discussion with Mike Stroz, Global Operations IS - Global QC Systems program manager at a major pharmaceutical company.¹

The goal: To harmonize all of the company’s QC labs around the world

Project details: The project began in 2006, when the company defined a strategy for data and sample management in the labs. A key task was to integrate the systems. At the end of 2009, the company was halfway through its worldwide rollout.

Early in the project, the team worked out a global process to follow. This process was designed to apply to the greatest proportion of the company’s operations and products. The occasional product or process that did not fit into this process model was left alone. The model was not “bent” to accommodate each exception, and the exception cases were not forced into the model. The team also prioritized products by starting with those that would carry the highest return if made paperless, i.e., the most common products that require and create the largest amount of data. The team made these highestpriority products paperless first and then kept working on the rest of the products from there. Additionally, where there were variations in methods, the team’s priority was to convert the most common methods first. So the team had several layers of prioritization in order to convert most quickly those items that the laboratories used most often.

Once an area begins its rollout, it faces a variety of situations; at any given time some products will be paperless, some will be hybrid and some will be entirely on paper. It could take several years to get everything converted, depending on the size of the area and the number of products involved. But the priority remains to convert the products with the highest volume or impact the soonest.

The company also defined a model for the layers of information it would have. The model looks like this:

For the labs to be paperless, the team determined that these were the systems that must be integrated into the model. The LIMS layer is used by QC management for scheduling and COAs (certificates of analysis). The execution layer is the ELN, where the analysts do all their work. The instrument data layer is the CDS, which is linked to the ELN layer to make all the data easily searchable.

In this model, each system interacts only with those immediately adjacent to it in the drawing. For example, the ERP interacts only with the LIMS. The LIMS interacts only with the ERP and the ELN, but not with the CDS or other instrument systems. Therefore the ELN collects instrument data so users can access that data in their electronic laboratory notebooks. Then the data required by the LIMS is sent to the LIMS from the ELN. Also, a critical feature in this model is its design that keeps people from having to switch systems. Thus, the processes around these “levels” are designed to keep the roles working within that particular system level.

Some detail at each level looks at things appropriate to that level. For example, the team defined where their samples were coming from: some came from SAP, others were ad hoc and still others came from other sources. The team also considered what review people needed to do within a level or who needed to see what information. Within a level, one department might need specific information or the laboratory might need to schedule samples. The team designed each system to accommodate these low-level differences.

However, their goal was to keep each system as usable right out of the box as possible. They did not want to spend much time customizing systems or trying to make systems do things they weren’t intended to do, so the team refused to accept from software vendors new system pieces that were immature or meant to extend what each layer would do. Also, they used one system for each level to set the standard.

ROI (return on investment): Mike claims that the company realized a 30 to 40 percent gain in resources as a result of being paperless. It saves time because employees no longer print documents to review, for example. Along the way, the team considered the company’s KPI (key performance indicators) and measured them.

Specific points: Mike makes the point that you must consider how much time and effort you will spend going paperless versus the benefit you’ll get from it or the money you’ll save. To do this, analyze how you run your business and identify where and how the benefits will occur.

Legal: The company’s legal department did not find the proposed paperless process to be an issue in and of itself. There were a variety of issues that came up along the way, but a technical solution was always found to address them.

Research Project: Millennium: The Takeda Oncology Company

The second example comes from a discussion with Craig Tulig, associate director of R&D systems at Millennium: The Takeda Oncology Company.² Millennium has two ELNs, one already implemented for chemistry and a second that is in its pilot phase for biology. The latter is the subject of this example.

The goal: To make scientists more productive by allowing them to easily search their data electronically and to give them quicker and more reliable access to their data.

Project details: The Millennium team wanted to make sure that they could input data so that it was highly searchable. This was especially important because this data is unstructured. Thus the team decided to be somewhat cautious and carefully addressed their data needs. They wanted to make sure that their data was captured in a high-quality manner.

A number of systems such as the reagents database and other related systems make up the overall Millennium strategy. However, the scientists see only their e-notebooks. For example, Craig said that they will be linking a homegrown LIMS into this strategy. Millennium’s ELN product is from the Symyx family of products. Even though they are not doing the same thing for biology that they did for their chemistry project, the team thought that it was important to have a single enotebook platform for Millennium and they made their selection through a rigorous evaluation process. Thus, both chemistry and biology are using solutions from the Symyx platform.

In the biology area, the lab notebook is the last paperbased system, as everything else is already paperless. At this time, the Millennium team has put much thought into what they want in a system and is now running the initial pilot to test their concept. That phase is expected to take three to six months. The purposes of this pilot are to verify that their solution is effective and that the data integration is fully realized.

Once the pilot phase is over, the first phase of rollout is expected to take place in the subsequent three-month period, followed by another phase of rollout in which labs have been prioritized into phases.

ROI: Because this is a research environment, Craig’s team believes that the “soft” benefits are the most important. However, he said that there is a noticeable difference between the time it took people to dig through paper notebooks and documents and the time it takes when they do an electronic search to get their data. This is important to the research area, and the value is not easily calculable.

Specific points: Craig’s advice is to establish your goals up front so that you can measure your project against them. He tells us to make sure that we define not just our goals but also the exact efficiencies we hope to gain, which will help direct the project.

Legal: In 2004, when the Millennium team began the chemistry project, they worked with their legal department to determine how to take precautions with the IP (intellectual property) within their strategy. They briefly had a hybrid system as the details were worked out but did not have to run in hybrid mode for long

Final points

Notice that neither company had the specific goal of becoming paperless. Rather, in each case they wanted to improve productivity or harmonize operations. To do so, they mapped their processes and made decisions on how to proceed. They went paperless because the paper pieces of the process were standing in the way of their productivity or operational goals. Keeping this in mind is key to maintaining perspective on your true goals and finding how to achieve them.

References

1. Telephone discussion with Mike Stroz on Friday, November 6, 2009.

2. Telephone discussion with Craig Tulig on Thursday, November 19, 2009.