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laboratory informatics Future prospects for LIMS

John Boother believes that these are exciting times to be in the LIMS business


redicting the future direction of the LIMS market provides an interesting challenge. Perhaps the safest and surest prediction is that there will be

change. LIMS is big business – a recent report from Kalorama Information1

suggests that the

market for LIMS will grow to nearly $1.5bn in 2015, spurred on by the desire of clinical diagnostic laboratories to handle larger amounts of data from molecular testing and sequencing. Increasing data generation in these and

other market areas, coupled with the growing expectation of seamless data transfer between a variety of communication devices (tablets, ELNs, mobile phones as well as PCs) anywhere in the world highlight the importance of technological advancements in the development of LIMS. Greater integration with laboratory instrumentation is likely to be another factor. One potential disadvantage of emerging

and developing technology platforms and the current absence of any formal LIMS data standards, however, is that LIMS soſtware may have compatibility issues, which could lead to greater cost of ownership. LIMS vendors who design their soſtware to be adaptable to change will benefit as well as their customers. Products that are adaptable will have longer lifetimes, meaning that the cycle to develop new products will be longer, reducing soſtware development overheads. In addition, products with the adaptability to meet future changes are more attractive to customers, giving them a better return on investment. For example, offering features that would be expected in either a LIMS or an ELN means that laboratory managers would not need to choose between adopting either a LIMS or an ELN or have to attempt to integrate both types of system. Te emphasis is on identifying the needs of the laboratory and finding a total solution that meets those needs.

Managing change Technological change is one issue, but there are other drivers of change, both internal and external, and this is where the adaptability of the LIMS is so important. Internal changes within a laboratory or its parent organisation could involve the adoption of new tests or a complete new testing regime; the introduction of new equipment; the replacement of older equipment;


changes in reporting requirements, or perhaps even taking on testing in a new market area (for example for contract testing laboratories or as result of a business merger or acquisition). So a LIMS that allows new work flows to be added and multiple work flows to be operated concurrently would help in this situation. Similarly, regulatory impact is critical. Any

particular standards found in any industry can be subject to update or change. Take clinical trials in the EU, for example. Te EU Clinical Trials Directive (20001/20/EC and 2005/28/EC) and subsequent UK laws covering the conduct of clinical trials in accordance with Good Clinical Laboratory Practice are well established. However new EU Clinical Trials Regulations2

were approved by the

European Parliament in April 2014 and are expected to become law throughout the EU in 2016. Tis new regulation is intended to overcome disproportionate regulatory requirements including high costs and a lack of




harmonisation of the applicable rules necessary for multinational clinical trials. Any of the changes described above could require changes to the way a LIMS is implemented, so flexibility in the product is essential, as well as the way in which LIMS vendors support their customers through change processes and whether they make any charges to implement these changes! Indeed, a recent survey3

A business case for LIMS Te role of LIMS has already extended beyond the original laboratory information management to provide business management capabilities as well. Systems for contract laboratories can already handle an extensive range of management functions from invoicing to consumable inventory control, but this is likely to expand in areas where the cost of running a laboratory needs to be monitored closely. Tis could range from monitoring the time required to carry out a test to the usage level of the instrumentation involved and the cost of reagents required. LIMS also has considerable potential to further branch out into other aspects of business management such as quality management, by providing a systematic resource for tracking, storage, auditing and reporting of data across all segments of a business or company.

References and Sources 1

2 carried out by Strategic

Directions International asked several hundred LIMS managers and knowledgeable users about their needs, capabilities, and trends relating to the LIMS market. Tis revealed that the top two criteria when choosing a LIMS vendor were service/support, and responsiveness/reliability of the LIMS vendors. With change comes the need for traceability. Whilst the ability to

3 prweb11171117.htm clinicaltrials/2012_07/press-releases/memo- 12-566_en.pdf

http://www.strategic-directions. com/_a/market-reports/index. cfm?action=3&sdi=-1747271820

John Boother is managing director of Autoscribe Ltd.

@scwmagazine l Autoscribe produces Matrix Gemini LIMS

track samples and everything that happens to them within the laboratory is a fundamental requirement of any LIMS, tracing any changes made to the LIMS set-up is also becoming more important for complete auditing of a system. Version control of screen designs is one example of where system auditing can be simplified.

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