Electronic Lab Notebooks: Paving the Way of the Future in R&D
Lysakowski, Rich, Doyle, Leslie, Records Management Quarterly
Managing intellectual property records electronically can be a daunting task. For organizations that are regulated by the Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and others, moving into the nebulous world of electronic records feels risky. However, electronic management of research and development (R&D) records is the way of the future. Most U.S. federal agencies have issued regulations or guidelines regarding the capture and usage of fully electronic records. For example, on March 20, 1997, the FDA issued a bonafide regulation that allows electronic records and signatures to be submitted in lieu of paper records and handwritten signatures. But representatives of the FDA, Patent and Trademark Office (PTO), and EPA have said they will not mandate particular technologies. In the wake of these announcements, pharmaceutical, chemical, biotech, and other regulated industries have been left clamoring for information on how to move forward confidently and benefit from the use of electronic laboratory notebooks and related recordkeeping systems.
Recently, researchers at TeamScience, a science-oriented software research company located in Woburn, Massachusetts, initiated a research study called the "R&D Team Computing Study." The study was commissioned by nine multinational corporations in the pharmaceutical, chemical, biotechnology, and related industries. The study detailed the vision, the business requirements, and the software functional requirements for companies to be effective using the new class of systems called R&D Team Computing Systems, that include the functions of electronic notebook systems but go beyond them to include sophisticated project data management and distributed team collaboration functions.
This article addresses the following issues: the unique computing requirements of R&D teams; current problems in the R&D software marketplace; why the web is not yet a serious place for R&D recordkeeping; why paper laboratory notebooks are obsolete; benefits that scientists will gain from collaborative electronic notebooks; the cost/benefit analysis of collaborative electronic notebooks; and a summary of the R&D team computing study results.
A primary goal of the R&D Team Computing Study was to compare and evaluate commercial candidates for integrated electronic laboratory notebooks, records management, document management, groupware, and collaborative computing systems that support both individuals and teams of scientists in R&D and testing laboratories. In addition to researching the systems themselves, we also compared and evaluated their suppliers' ability to address the business needs of the companies in the targeted industries. Only commercially available systems were evaluated because people wanted technologies that they could use to implement systems immediately. Although this study evaluated individual products, we wanted to use this opportunity to construct a framework for the evaluation of all R&D team-computing systems. A related goal was to construct a detailed blueprint for systems based on the requirements identified.
A primary study conclusion is that no existing vendors or products on the market meet the full range of needs required for electronic lab notebooks or R&D team-computing systems. A few generic systems are moving in the right direction, but still require an inordinate amount of work to sufficiently focus them on the needs of R&D and testing organizations. Commercial "out of the box" systems will likely require 3 to 5 more years to implement the majority of specialized functions required by R&D professionals working on global projects.
THE R&D TEAM COMPUTING STUDY
Teams ranging from 3 to 25 people working in large R&D and testing organizations of 5,000-10,000 people were the targets for the study. The teams worked in many different parts of basic and applied research, applied research, product development, quality assurance/quality control laboratories, and manufacturing labs. …