Laboratory automation and laboratory informatics Building a Smart Laboratory 2012 Many LES allow users to adopt their


way of working on a natural way. Typical procedures include: • Worksheet-based execution: Convert existing paper-based worksheets into electronic forms.


• SOP-based execution: Overlay data entry points, grids or other prompts on existing SOP. Tis supplements the SOP with real- time data collection and confirmation, in addition to ensuring that analysts are following the documented procedures.


• Define unique workflows required for routine procedures. Once the process has been mapped based on the desired workflow, the analyst can then be walked through the test process using the workflow.


Benefits of an integrated laboratory execution system (LES)


Eliminate manual data entry and reduce transcription errors


Automated SOP enforcement Automate calculations No user training required Single point of truth (master record) Supporting paperless lab initiatives


it is a laboratory content management system. By adding workflow elements and providing facilities for the management and storage of other documents associated with laboratory operations (worksheets, SOPs, safety information, reports, PDFs, office documents, images, etc.) in practice an SDMS can evolve into a more comprehensive single informatics solution for some labs. However, an SDMS is essentially an


‘event-driven’ system that gathers data, which may limit some of its capabilities relative to the other informatics tools, and is therefore more frequently seen as a system that is complementary to a LIMS or an ELN. Nevertheless, the principle on which the SDMS is based is that it aggregates records into a logical collection associated with a specific entity such as a programme, project, experiment, product, sample, etc. to provide a readily accessible collection of relevant information. Embedded in an SDMS will also be the means to provide appropriate security of the records by means of access control, audit trail, authorisation and change management.


What is an ELN? What is an SDMS?


A scientific data management system (SDMS) is, in its basic form, a system used to manage electronic records generated by laboratory instruments. Typically, an SDMS will provide facilities for long-term data preservation, accessibility and retrieval. It is complementary to other informatics systems such as LIMS and ELNs in the sense that it can provide a common repository for experiment and sample-related data files. In this way it provides a more consistent approach to managing laboratory data, dispensing with assorted local repositories and offline media, such as CDs, DVDs, tape, etc. As with many other lab informatics


tools, the lines between a LIMS, ELN and an SDMS are at times blurred through the incorporation of additional features to complement the core functionality. Te basis of an SDMS is a means of collecting data files from a wide range of laboratory instruments and storing them, along with metadata, in a uniform way in a database. In other words,


14


In its simplest form, an electronic laboratory notebook can be considered to be a direct replacement for the paper lab notebook. In this instance, it can provide the generic functionality to support ‘broad’ scientific documentation processes required for patent evidence creation, cross-discipline collaboration and general record keeping. However, the integration capabilities that we readily associate with information technology raise the possibility of a tighter coupling of other labsystems into the ‘electronic laboratory notebook’. In other words, can the information that is currently printed from other 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, compound registration, etc. 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 4 illustrates the


relationship between ‘broad’ (generic) and ‘deep’ (specific) systems. Another way of looking at this is to


define an information structure (see Figure 2) that identifies how different systems fit into the laboratory architecture. Te triangle represents the different layers of abstraction that exist in R&D information flows. Tese are almost always handled by different systems. Above the experimental layer is a management context that is handled by


“In its simplest form, an electronic laboratory notebook can be considered to be a direct replacement for the paper lab notebook”


traditional IT tools used elsewhere in the enterprise. Cross-discipline collaboration tends to happen around the experiment layer. Below the experiment level there is an increasing specialisation of data types and tools, and only a few systems are comfortably deployed across workgroups. From a patent perspective, the


experimental layer is crucial as it captures what the scientist is thinking and doing, and therefore provides 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. Whilst 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 in these processes. Te generic function of an electronic


laboratory notebook supports the ‘experimentation’ layer and contains abstractions from the lower data levels. So in terms of ‘what is an electronic laboratory notebook?’, the CENSA[3]


definition –


‘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 therefore mean different things to different people. For this reason, 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.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36