and some unstructured data. Specifically designed to meet the requirements of the GxP environment. Simplifies repeated operations. Supports electronic SOPs. LIMS: Sample-centric. Primarily designed


to handle structured data and offer sample and test management, batch operations and industry-specific workflows. Secure lab information hub. Supports compliance. SDMS: Data-centric. Handles data files


from lab instruments, meta-data, documents and the relationships between them. Unravelling the functional and business


requirements is an essential first step in any informatics project and it is easy to fall in to the trap of focusing on the solution, i.e. we need a LIMS, we need an ELN, etc., when the focus should really be on the underlying problem. Although the convergence issue in the ELN market creates some confusion, it also highlights the fact that there are a number of viable alternatives to replacing a paper lab notebook. By fully understanding the problem and identifying the functional needs of the laboratory, the solution may be found in alternative informatics applications; the challenge is to find the best overall fit for the laboratory’s workflow. One specific aspect that generally


creates considerable concern during vendor assessments is the extent of the ‘fit’ of the vendor’s product to the list of functional requirements. In some cases this may lead to a dilemma about ‘buy’ or ‘build’ and furthermore, if the decision is ‘buy’, what to do about the missing functionality. As the informatics market has matured,


most products offer greater degrees of configurability in order to avoid the need to write code to address any custom requirements. Tis enables an organisation to purchase a commercial product and configure it in ways that meet functional and cosmetic requirements, without causing any incompatibility with the core code. Customisation, involving writing code, can in some circumstances put significant barriers in the way of future product upgrades and create high costs for both maintenance and further development. Tere may be instances where an


organisation may choose to develop informatics solutions internally if it feels that its requirements cannot be adequately addressed by commercial products. In this case, the financial implications need to be given considerable attention. Although the development cycle, using in-house, paid-for labour, may undercut purchasing costs, it is


the on-going cost of maintenance, support and the retention of knowledge that can add considerably to the total cost of ownership.


Laboratory instrument systems


Te range of instruments and computerised systems used in laboratories is very wide, extending from simple instruments such as pH meters and analytical balances to sophisticated chromatographic and spectrometric systems. However, all are similar in the fact that soſtware is used to manage the operation of the instrument, in read-only memory (ROM) or in a separate computer system to provide control of the instrument, as well as acquiring, processing, storing and reporting results. Regardless of the type of instrument or


system used, they form the foundation of the smart laboratory, as they are involved with generating the analytical data used within the laboratory. Information is abstracted from the data by a variety of mechanisms and used to make decisions. However, without the foundation layer comprising the analytical instruments and systems, the informatics portion will not function.


Simple analytical instruments


For a simple analytical instrument (e.g. a balance) the soſtware is integral. It is capable of storing user-defined parameters or methods, but typically there is no data storage capability offered. Terefore, data is traditionally captured by either observation into a laboratory notebook or by a printout from the instrument. However, these instruments are oſten critical in determining the quality of the result and require a different approach to integration within a smart laboratory. As there is no data storage capability, the


instruments need to be interfaced to a system with storage functions, such as a LIMS or ELN. Interfacing needs to be direct with the receiving system, however as more intelligence is being built into simple systems, some balances have touch screens that are able to act as terminals for LIMS and ELNs. In other cases, vendors make data capture


systems to capture and buffer data from these instruments and add integrity features, such as the identity of the analyst making the measurement, data and time, sample information and audit trail entries to comply with regulatory or quality guidelines.


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