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Information: Laboratory informatics tools Building a Smart Laboratory 2017


An ELN system (like the bound laboratory notebook) has several roles:


A place to do science – a working environment;


A place to write up the experimental work; A record of the work; and A long-term preservation mechanism.


record keeping. However, the integration capabilities raise the possibility of a tighter coupling of other laboratory systems into the ‘electronic laboratory notebook’. In other words, can the information that is currently printed from other laboratory systems, cut out and pasted into the paper lab notebook, be electronically entered or linked directly to the electronic laboratory notebook? For example, systems that provide


chemical structure drawing, structure and sub-structure searching, and compound registration are an integral part of the chemistry laboratory’s process, and therefore would be expected to become part of an electronic solution. Similarly, other scientific disciplines will have specific requirements consistent with their particular laboratory processes. Figure 5 illustrates the relationship between ‘broad’ (generic) and ‘deep’ (specific) systems. In this context, the ‘notebook’ functionality (see Figure 1) is addressed by the ‘broad’ layer, whereas the discipline-specific functionality penetrates the ‘interpreted/processed data’ layer in Figure 1. From a patent perspective, the


‘experimental layer’ of Figure 1 is crucial as it captures what the scientist is thinking and doing, and therefore will provide the evidence of conception and reduction to practice of the ‘invention’. In broader intellectual property (IP) terms, it is the ‘experiment’ layer that constitutes a record of the laboratory’s work and as such contributes to the scientific knowledge repository. For as long as this repository resides on paper, the ability to access, collaborate and share scientific knowledge is constrained. Te implementation of an ELN therefore offers a significant opportunity to bring about greater efficiencies. But a clearly defined understanding of


the role that the ELN is going to play in a given organisation is absolutely essential at the start of an electronic laboratory notebook project. As discussed, an electronic laboratory notebook supports


24


the ‘experiments’ layer, and also contains abstractions from the lower data levels (see Figure 1). So the CENSA[2]


definition


of an electronic laboratory notebook as ‘a system to create, store, retrieve and share fully electronic records in ways that meet all legal, regulatory, technical and scientific requirements’ is all encompassing and can mean different things to different people. An ELN can serve the organisation


in three ways: it can take advantage of the capabilities of IT to improve the ability to acquire, manipulate, share and store data (productivity); it can facilitate communication and sharing in real-time across multi-disciplinary and multi-site teams (collaboration); it can provide a scientific knowledge repository that can be easily accessed to recover records of the laboratory’s work (content/knowledge management).


“ The wide range of commercial systems on the marketplace has become increasingly sophisticated over the years”


Te way in which laboratory notebooks


are used is largely dictated by the United States’ patent system which, unlike the rest of the world, is based on ‘first to invent’. Te need to be able to demonstrate who really was first to invent requires the laboratory notebook to be an authentic and trustworthy record that describes the concept and its reduction to practice, and for it to be signed by the author and corroborated by an impartial witness. Tere are two factors why the migration away from paper lab notebooks has taken so long: the reluctance of lawyers and patent attorneys to gamble on the legal acceptance of electronic records in patent interferences and patent litigation without any case law; and the lack of confidence in our ability to preserve electronic records over several decades. One of the challenges to a successful


ELN implementation is identifying exactly what role the ELN will play. Te term ‘electronic laboratory notebook’ is inherently ambiguous. In most cases, the ELN is expected to do more than just replace the paper lab notebook. Te paper lab notebook is a simple authoring tool, and any electronic authoring tool capable of generating a compound document will serve as a


replacement. For some companies this has proven to be the case. Te combination of Microsoſt Office, SharePoint services and a means of preserving documents (e.g. in PDF – portable document format) has proven to be an adequate replacement for paper. But if more functionality than this is needed – for example, integrating various chemistry or biology-centric functions, or other discipline-specific tools – then we are really talking about an electronic laboratory rather than an electronic laboratory notebook.


Chapter summary


Te four major laboratory informatics systems serve different basic functional requirements, but convergence and increasingly sophisticated technologies are creating a good deal of overlap between the systems. So when it comes to choosing the right solution, it’s far better to start by defining an objective or describing the problem to be solved, rather than placing the initial focus on a ‘solution’. Just deciding ‘we need an ELN’ or ‘we need a LIMS’ should not be the starting point; it’s far better to think about the big picture, i.e. the end-to- end business process that embraces the role of the laboratory, the specific workflows, the communication and collaboration requirements, and the integration requirements. Once these requirements are defined, then the task of finding a solution is more straightforward. n


Configuration versus customisation


The difference between customisation and configuration is very simply the difference between writing additional code and setting (configuring) in-built parameters in order to achieve some desired functionality. Customisation is generally considered a poor choice as it increases costs, complexity, and risk, and makes it more difficult and more expensive to upgrade software in the future. In a regulated environment, custom code will require extra validation steps. It may often be a symptom of bigger problems, including a mismatch with a company’s requirements or a lack of project controls during implementation. Most laboratory informatics systems are designed to be configurable, and a major activity during implementation is to undertake the entire required configuration to meet functional requirements. Once configured, system upgrades will automatically carry through existing configuration.


www.scientific-computing.com/BASL2017


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