It's all down to interpretation
Managing, analysing and sharing information across departments and sites remains a big challenge for most life science companies. Nowhere is that more apparent than in sending data from laboratory instruments to LIMS, ERP or other corporate software. That's because it's not just a matter of simply transferring the data; it's about data management too, including data security and regulatory compliance.
Closer links between instrument software and LIMS or other information management software is one way to smooth the process. At the same time software must be easier to set up, use and maintain.
Configurability is one of the big trends seen among LIMS companies, says Frost and Sullivan sector analyst Charanya Ramachandran. 'The main factor influencing the move from conventional customisation to configurability is that the latter enables vendors to retain the core capability of commercial off-the-shelf solutions as well as adapt product features to cater to customers' requirements,' says Ramachandran in a newly-published report on Western European markets for LIMS.
Laboratory instrument companies like Waters, Agilent and others have responded by extending the capabilities of their mass spectrometry, chromatography data system and scientific data management system software with the aim of satisfying these demands for greater configurability and tighter integration. Some have also been making good any missing parts of the scientific software infrastructure in their products by targeted acquisition (see Scientific Computing World, October/November 2005). Of course it doesn't hurt that software is a growing component of instrument company revenues. Overall IT spending in the life sciences industry is set to rise at around 16 per cent per annum from $17bn in 2004 to nearly $50bn in 2011, according to a recent Frost and Sullivan survey.
By extending their software offerings, instrument manufacturers also hope to bind users more tightly to their own range of products. But that's a trend that many life science companies are likely to resist.
Research and development staff are notoriously independent about instrument selection and laboratories usually have instruments of different vintages and from a range of suppliers. This leaves the field open to specialist integrators - companies such as Labtronics and Csols - to continue to prosper by providing instrument interfaces with a high degree of configurability that are, at the same time, easy to install and use.
Labtronics has been around since 1986 and marketing manager Dave Liptrott sees the company's main competition coming from in-house integration by company IT departments rather than encroachment by instrument LIMS or ELN software made more flexible by the addition of web service. But although these internal integration solutions efficiently transfer data from the instruments, they often do little else, says Liptrott. This is because IT departments don't realise how much can be achieved through the interface itself, he says. In-house interfaces are more likely to break when a new LIMS version is installed or need additional coding when a new instrument is installed.
As a default, commercial interfacing software can accept data from a range of laboratory instruments and can be configured to perform a host of tasks, including making calculations or adjustments to data - to correct against a standard sample, for example. It can also be used to manage the maintenance, calibration and validation of balances or other laboratory equipment without its own software, says Liptrott.
For added robustness the interface can be embedded in the instrument software itself. One of the most powerful features of Labtronics' most popular integration product - LimsLink - is the capability for the Labtronics integration solution to be directly embedded within some of the most widely available chromatography data systems (CDS), a feature first introduced in 2003. The newest version of LimsLinkCDS allows users to access a LIMS directly from menus within their CDS. An analyst can automatically create sequences from LIMS work-lists, run their analysis, and report sample results to their LIMS, without having to leave the instrument software. They do not need to have any special knowledge of either the interface or the LIMS, making the interface much simpler to work and eliminating the need for training in yet another software product.
LimsLink has been around for more than 10 years and Labtronics continues to roll out improvements to the software. Last year, the company released LimsLink versions to interface with Agilent's ChemLMS LIMS and two applications sold by Scientific Software (now part of Agilent) - EZChrom Elite, a connectivity module that integrates EZChrom CDS with more than 30 third-party LIMS packages, and OpenLAB, a laboratory software framework. The year also saw Labtronics release NEXXIS qELN, an electronic laboratory notebook for quality control/assurance laboratories and updated versions of its Collect XL and BalanceTalk XL data integration software for RS232 and TCP/IP capable instruments.
Over the lifetime of LimsLink, Labtronics has been able to build relationships with software developers and instrument manufacturers. It can also draw on a wide range of installations to show to prospective customers. This is an increasingly important requirement. More and more companies are asking for return-on-investment (ROI) estimates from software companies, says Liptrott.
Failure to take account of instrument-interfacing issues can lead to problems in LIMS implementations, so proper planning is needed. As instrument-to-LIMS interfaces become increasingly sophisticated, laboratories are realising the importance of developing a full understanding of their instrument-interfacing requirements, as part of their LIMS project. It used to be common practice to leave instrument interfacing until the end of a project, or even to drop interfacing from a LIMS project to cut costs. Now LIMS integration with laboratory instruments 'has become a basic requirement' of a LIMS installation rather an afterthought and companies are requesting its inclusion at the outset of a project, says Liptrott.
One of the greatest benefits of instrument-LIMS interfacing is more reliable data. Around 50 per cent of all laboratory data is still being manually transcribed into laboratory systems, says Liptrott. This is a huge improvement on a few years ago, when it was 70 per cent. But the result is a typical error rate of around three per cent, he says, something that is not acceptable in highly regulated sectors such as the pharmaceutical industry. In the wake of some high-profile drug failures, regulatory requirements have become one of the main drivers of IT spending in the life sciences sector. 'There is a tremendous rush towards compliance-related IT spending, something similar to what was witnessed during the Y2K days,' says Frost and Sullivan analyst Raghavendra Chitta. But the life science companies are also interested in value. Software tools must be 'capable, interoperable and run on existing infrastructure', with easy integration to legacy systems, he says.
'There is a lot of activity among global pharmaceutical companies,' agrees Liptrott. Many of them have older LIMS that need replacing; at the same time the companies would like to standardise their procedures across different sites and countries. Liptrott cites Labtronics' recent deal with US biotechnology company Genzyme as an example of this trend. Genzyme had expanded rapidly and needed to deal with a substantial increase in the amount of drug data that needed to be processed and archived while complying with the heavy regulation experienced by the drug industry.
The company decided to create global product data management system to eliminate human error in data entry and to increase lab productivity. It installed a new LIMS and scientific data management system (SDMS) together with LimsLink, which provided bi-directional connection between the software and all of the Genzyme's laboratory instruments while complying with FDA 21 CFR Part 11. Now it has been tested and validated, Genzyme is rolling out the system on sites around the world.
The potential for growth in the sector prompted another veteran integration specialist, CSols, to launch L4L Pharma, an Oracle-based LIMS/instrument integration product designed specifically for the pharmaceutical industry, early last year. This month (February 2006) CSols plans to release an updated version of L4L Pharma and of its general integration product Links for LIMS with improved performance and additional interfaces for Waters CDS systems and Thermo Electron LIMS systems.
The overall LIMS market seems set to grow with sales in Western Europe forecast to increase from $90m in 2005 to $163.4m by 2012, according to Frost & Sullivan's Ramachandran. Liptrott expects many LIMS customers to replace existing installations with updated software over the next two years. Some LIMS are pretty old, he says while sector consolidation has left other companies with systems that are in limbo - that is, although they are still supported they are not being actively updated.
Consolidation among instrument and laboratory management software firms may be the current trend but independence has its benefits.
'We're vendor neutral,' says Liptrott. Users don't want to be tied to a specific instrument supplier, and companies also need to integrate older and less sophisticated instruments including pH meters and balances. So Liptrott doesn't think the demand for specialised LIMS interface software is going to weaken. The strength of the integration companies is in their links with many suppliers and they will continue to prosper in the absence of truly open standards for scientific data.
A silica solution
Ineos Silicas, a manufacturer of silica and alumina technology, has recently upgraded its LIMS to LabWare's v5.02. Ineos Silicas manufactures products such as liquid and solid silicates, gel and precipitated silicas, and a range of zeolites for detergent and other applications.
The LabWare LIMS implementation at Ineos replaced the previous LIMS, which had been operating at the site for more than 10 years. The LabWare implementation provided the requirements for all the laboratories, including instrument integration. The system is linked to IP21 (a plant information management system from AspenTech), as well as Ceris (an in-house environmental monitoring system).
Together, the two systems provide information on how product quality is affected by operating conditions. The system uses LIMSBasic, LabWare's macro language, while IP21 uses an SQL-style database. Having considered a number of methods for transferring data, Ineos opted to export the data from 'test complete' events in the LIMS as a CSV file, which is then imported into IP21. This method enabled the users to check what information was sent from LIMS. IP21 scans the relevant folder every 60 seconds, meaning that at most it is 60 seconds from data entry in LIMS to it appearing in IP21.
IP21 scans the folder for new files, parses them and assigns data to two sets of tags. IP21 works by tags; essentially one set is by product, the other by sampling point. So, users can view how the manufacturing process of a product developed over a series of campaigns, or watch a product-change ripple through the plant.
Beverley Bradbury and Martin Cheek, both of Ineos Silicas, are very happy with the integration: 'It was inexpensive to set up, only taking two weeks or so, and has been very efficient, with neither system showing any noticeable drop in performance. What is truly exciting is that all the coding in both systems was written without the need to bring in consultants.'