LII:A Science Student's Guide to Laboratory Informatics

Title: A Science Student's Guide to Laboratory Informatics

Author for citation: Joe Liscouski, with editorial modifications by Shawn Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: November 2023

Introduction

An undergraduate science education aims to teach people what they need to know to pursue a particular scientific discipline; it emphasizes foundational elements of the discipline. In most cases in current science education, the time allotted to teaching a scientific discipline is often insufficient to address the existing and growing knowledge base and deal with the multidisciplinary aspects of executing laboratory work in both industrial and academic settings; the focus is primarily on educational topics. Yet employers in science-based industries want to hire people "ready to work," leaving a significant gap between the goals of science education and the background needed to be productive in the workplace. One example of this gap is found in the lack of emphasis on laboratory informatics in laboratory-adjacent scientific endeavors.

The purpose of this guide is to provide a student with a look at the informatics landscape in industrial labs. The guide has two goals:

1. Provide a framework to help the reader understand what they need to know to be both comfortable and effective in an industrial setting, giving them a starting point for learning about the product classes and technologies; and,
2. Give an instructor an outline of a survey course should they want to pursue teaching this type of material.

This guide is not intended to provide a textbook-scale level of discussion. It's an annotated map of the laboratory portion of a technological world, identifying critical points of interest and how they relate to one another, while making recommendations for the reader to learn more. Its intent is that in one document you can appreciate what the technologies are, and if you hear their names, you'll be able to understand the technologies' higher-level positioning and function. The details, which are continually developing, will be referenced elsewhere.

Note that this guide references LIMSforum.com on multiple occasions. LIMSforum is an educational forum for laboratory informatics that will ask you to sign in for access to its contents. There is no charge for accessing or using any of the materials; the log-in is for security purposes. Sign-in to LIMSforum can be done with a variety of existing social media accounts, or you can create a new LIMSforum account.

What's lacking in modern laboratory education?

The science you’ve learned in school provides a basis for understanding laboratory methods, solving problems, conducting projects/research, and developing methods. It has little to do with the orchestration of industrial lab operations. That role was first filled by paper-based procedures and now firmly falls in the realm of electronic management systems. So why is your laboratory experience in your formal education different from that in industrial labs? After all, both include research, testing, chemistry, biotechnology, pharmaceutical development, material development, engineering, etc.

Educational lab work is about understanding principles and techniques, developing skills by executing procedures, and conducting research projects. Industrial work is about producing data, information, materials, and devices, some supporting research, others supporting production/manufacturing operations. Those products are subject to both regulatory review and are subject to internal guidelines. Suppose a regulatory inspector finds fault with a lab's data. In that case, the consequences can range from more detailed inspection and, if warranted, closing the lab or the entire production facility until remedial actions are enacted.

Because of the importance of data integrity and quality, industrial laboratories operate under the requirements, regulations, and standards of a variety of sources, including corporate guidelines, the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the International Organization for Standardization (ISO), and others. These regulatory and standard-based efforts aim to ensure that the data and information used to make decisions about product quality is maintained and defensible. It all comes down to product quality and safety, so for example, that the acetaminophen capsule you might take has the proper dosage and is free of contamination.

Outside of regulations and standards, even company policy can drive the desire for timely, high-quality analytical results. Corporate guidelines for lab operations ensure that laboratory data and information is well-managed and supportable. Consider a lawsuit brought by a consumer about product quality. Suppose the company can't demonstrate that the data supporting product quality is on solid ground. In that case, they may be fined with significant damages. Seeking to avoid this, the company puts into place enforceable policy and procedures (P&P) and may even put into place a quality management system (QMS).

As noted, labs are production operations. There is more leeway in research, but service labs (i.e., analytical, physical properties, quality control, contract testing, etc.) are heavily production-oriented, so some refer to the work as "scientific manufacturing" or "scientific production work" because of the heavy reliance on automation. That dependence on automation has led to the adoption of systems such as laboratory information management systems (LIMS), electronic laboratory notebooks (ELN), scientific data management systems (SDMS), instrument data systems (IDS), and robotics to organize and manage the work, and produce results. Some aspects of research, where large volumes of sample processing are essential, have the same issues. Yet realistically, how immersed are today's student scientists in the realities of these systems and their use outside of academia? Are they being taught sufficiently about these and other electronic systems that are increasingly finding their way into the modern industrial laboratory?