The pharmaceutical industry faces a dilemma every day. On the one hand, the overall success of the industry relies on painstakingly thorough R&D, testing, and trials that, ironically, eliminate the vast majority of product ideas and eventually yield a relatively small number of safe and effective products. However, the research, development, lab testing, and clinical trials necessary to get a new product to market are hugely expensive. In September 2017, Former FDA Commissioner Scot Gottlieb told the members of the Regulatory Affairs Professional Society (RAPS), “We’re on an unsustainable path, where the cost of drug development is growing enormously . . . We need to . . . make the entire process less costly and more efficient. Otherwise, we won’t continue to realize the practical benefits of advances in science, in the form of new and better medicines.”
The challenge for pharmaceutical companies, then, is to discover ways to make product development less expensive without making it less effective – to learn how to work more productively without sacrificing accuracy or precision.
A leading-edge ELN (Electronic Laboratory Notebook) designed for use by pharmaceuticals helps companies achieve both of these goals.
Are you skeptical? Read on to discover:
Before we address how an ELN helps labs increase productivity and reduce costs, let’s define what an ELN is and how it differs from a LIMS (Laboratory Information Management System).
Put simply, an ELN is a digital version of the ubiquitous traditional lab notebook used for hundreds of years by researchers in many fields. Like a paper notebook, an ELN documents thousands of details about lab activity: Who did what? When, where, how, and why did they do it? What happened?
Notice the level of detail suggested by these questions, and how specific they are to an individual lab. That’s a key feature of an ELN; it’s designed to manage unstructured data and adapt to changing workflows. That feature is also a critical difference between an ELN and a LIMS.
A LIMS is designed to manage structured data through workflows that are tightly regulated. Traditionally, LIMS data gathering and management has focused on capturing and analyzing data throughout the lifecycle of the sample. Implementing a LIMS increases the lab’s standardization and accuracy among samples and tests, and also guides and records the usage, maintenance, operation, and calibration of equipment.
There’s disagreement over whether a leading-edge lab should implement an ELN, a LIMS, or a combination of the two. (We will address that issue later.) For now, we’ll focus on the ELN.[bonusPoints]
Why – exactly – does a pharmaceutical lab need an ELN?
We’re not here to malign the efficacy of the tried-and-true paper notebook. However, consider the limitations of paper notebooks when it comes to:
An ELN eliminates these difficulties associated with paper notebooks and provides researchers with tools and integration that a paper notebook just can’t provide. For those reasons, an ELN is crucial for cutting-edge pharmaceutical labs. Specifically, an ELN provides:
You’ve decided that an ELN makes sense for your lab. Now you need to select an ELN that will serve you well today and into the future. What traits make an ELN powerful, adaptable, and easy to use?
Spreadsheet functionality tops our list of best traits for several reasons. One is that a spreadsheet makes data entry easier and aids data organization. Spreadsheets can be formatted to fit the work processes of the labs ensuring that Methods and SOPs are followed. It allows data to be sorted, placed into subsets, and stored as structured data for later use. With spreadsheets researchers can calculate statistics in seconds, plot points on a chart, and make graphs of sample results. Complex calculations and conditional statements can be coded into most spreadsheet programs. This allows them to be tailored to fit the needs of an individual lab.[captionedPic]
A second benefit of spreadsheet-based ELNs is that they have been scientists’ “tool of choice” for decades now. Excel is now over 30 years old. It’s more dynamic than it used to be, but is essentially the same tool researchers have relied on for years. An ELN based on a spreadsheet feels ‘right’ to many researchers. That results in decreased training costs resulting from 1) greater acceptance among scientists who view a spreadsheet as a valued tool, and 2) easier and faster integration since that format is familiar.
No ELN can guarantee that a lab will be compliant. Human actions ultimately determine whether a lab meets compliance standards. However, the software needs to meet technical requirements for compliance including a comprehensive and easy-to-follow audit trail and a framework that encourages lab-wide SOPs that meet compliance guidelines.
The most common objection to a cloud-based solution is data integrity. However, a responsible ELN provider will secure your data with redundant server data and backups, and will also provide regular archives to you for local storage. This guarantees your data can not be lost and allows you to switch providers if needed without sacrificing data continuity.
“Implementing an ELN occurs as a transition–not at a fixed point in time.” Key people in your transition team will need to repeat that saying to themselves and others during the process. You’ll facilitate the implementation if you:
SciCord is a spreadsheet-based hybrid ELN/LIMS that combines the compliance and structured aspects of a Laboratory Information Management System (LIMS) with the flexibility of an Electronic Laboratory Notebook (ELN). The ELN and LIMS functions integrate seamlessly and enable your company to quickly reap the benefits of enhanced data and time efficiencies as you continue to meet compliance standards and follow GLP.