What are the disadvantages of the traditional, paper-based laboratory environment?
Meek: We could start by asking "what are the benefits” of using paper, which are obvious – paper is for the most part easy to use, it’s often convenient, frequently portable and much of the time legally defensible. And paper requires no “user training” so for the most part, new users can be trained on a process and quickly accomplish the task. Those are the positive aspects of paper. BUT, as you’d expect, the downside to paper is greater than the upside. Using paper-based methods for sensitive and complicated laboratory workflow creates a number of security, expense and productivity challenges. First of all, paper reports or workflow documents introduce significant security risks into what should be a completely secure process.
Paper processes also always introduce a human factor, and any human activity is inherently prone to errors to some degree. Organizations have to keep strict controls around their paper processes because they must control document access, version control, and cataloging the information to ensure that it can be located when required. Paper-based processes are costly, both in terms of the physical purchase of paper and in terms of the human capital that is expended to manually handle the process – human capital that is probably highly skilled and trained for scientific research and laboratory processes, not managing paper reporting. So there's a productivity factor in the cost equation to using paper.
Finally, in the current economic climate where every success factor, paper processes represent the antithesis of collaborative efforts. Today’s pharmaceutical company works in collaboration with academia, Contract Research Organizations (CROs), and partner biotechnology companies. Their data is spread across these organizations. Paper isn’t “searchable” and in this era of distributed research and development and outsourced testing, paper-based processes represent barriers to collaboration and a time drain on sharing valuable scientific information.
How does the paperless laboratory concept overcome these issues?
Meek: More and more laboratories are realizing that the investment they’ve made in setting up the state-of-the-art laboratory is not being fully optimized and they’re looking for ways to optimize that investment. The typical lab has expensive instrumentation and other laboratory equipment, all of which are generating data of some kind. Each of these instruments, if siloed, requires that a human has some interaction with that data to collate it with data from other instruments and compile reports. A fully integrated laboratory will connect instrumentation to a central data system, such as a Laboratory Information Management System (LIMS) so that data storage and reporting is automated. You can imagine how this situation becomes more complicated when there are multiple laboratories across different geographies working together across an organization. Also in many cases lab data is required by management at some point to satisfy decision making that is reliant on key business metrics which some of the lab data may provide. In a manufacturing environment, this will require that the lab is fully connected with other existing enterprise systems, such as ERP, MES, PIMS, etc.
So what’s occurring now with the paperless lab concept is that many companies are looking for ways to optimize the ROI for their lab investments. The key to this is integration of the lab itself, as well as connectivity of the lab with the rest of the organization.
In what ways does going paperless make a laboratory more efficient? Meek: Efficiencies in the lab come from streamlining workflow and automating processes. When the lab is fully integrated, that is that the instruments and other information systems are integrated with the LIMS, then all data collection and analysis is automated, freeing up the lab’s scientists to focus on science and more value-added revenue-generating activities. The reduction in time spent performing manual paper-drive tasks can produce an enormous improvement in productivity and also cost savings. For example, a modest reduction, say 20% in man-hours spent on paper-based efforts can produce hundreds of thousands of dollars in annual savings. It’s worth thinking about how much more revenue could be generated by those man-hours if they were spent on novel research instead of paper-based data collation and reporting processes or if a problem with production was discovered and the organization was able to react even one hour earlier in the process. This is the value many companies are seeing when they fully integrate their labs and connect the labs with the rest of the organization.
How does a laboratory begin to take steps towards implementing the paperless concept?
Meek: We’re advisors to our customers and the first thing we look at is the landscape of the lab. How is the lab set up, what instruments are in place or are planned for the future, what is the workflow required? It’s important to ask these seemingly basic questions because often the existing workflow isn’t the one that the lab actually wants – but it’s the one that’s in place. So part of implementing a paperless lab is to find a consulting ally that can honestly assess the situation in the lab and lay out a plan that will be flexible enough to grow with the lab and the business into the near future. Once this assessment is complete and an optimum workflow has been identified, the work can begin to make recommendations for integrating all those disparate instruments and connecting the lab’s output with key business metrics for management to use.
What tools are available to help companies achieve paperless status and ensure a smooth transition? Meek: The paperless lab concept has been talked about off and on for a number of years and each time it resurfaces the technologies that support this movement are a little bit closer to fully achieving the goal. This time around we’re closer still and a number of new technologies are now available that can fully integrate even the most heterogeneous of labs. This is an important distinction to make because most labs will have a fairly broad spectrum of vendors installed, something which in the past has been the perceived and sometimes practical obstacle for fully integrating the lab. The problem, up until now, has been the cost to integrate different software systems and equipment from each of these independent instrument vendors. But newer technologies based on open standards have led to big opportunities for life sciences labs today. At Thermo Fisher, we’ve spent time developing Integration Manager and Data Manager, which transform data from any instrument and deliver it to any source. While importing the final result is crucial, this solution takes it further by enabling scientists to see their real analytical data, chromatograms, mass spectra, and results from other instrumentation regardless of the instrument supplier. This type of automated data acquisition and point-to-point data distribution across the enterprise is what is enabling today’s paperless lab.
Are a significant number of pharmaceutical companies beginning to move in the paperless direction? Meek: We have had a tremendous response to CONNECTS. It is important to understand that life sciences industries are telling us that they want to get to a paperless lab. With CONNECTS, we are in a strong position to help our customers tackle this problem. We ensure that they understand that this is a process which starts with an evaluation of their existing organizations processes and how they are using their current software and hardware. We look at what works today and where paper-based, manual processes create bottlenecks that integration could address.
We are working with several customers at the moment to implement paperless lab projects. This is a customer-driven initiative, and our customers have just reached the point where they see the value in going completely paperless.