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Advancing technology in labo-ratory instrumentation alongwith higher-throughputprocesses are generatingmassive volumes of analyti-

cal data – even terabytes per project.The challenge is to automate and inte-grate laboratory operations and proce-dures wherever possible in order tomanage and process these growing datavolumes more effectively. A LIMS (Lab-oratory Information Management Sys-tem), like any other information sys-tem, becomes more responsive and pro-ductive when it is integrated with othersystems and applications in the labora-tory environment. Integrating LIMSwith analytical instruments not onlyautomates laboratory functions but alsoprovides data-sharing benefits that addvalue to the original investment.

LIMS implementation tends to be ahigh profile undertaking, and effectiveinstrument integration can provide apositive and visible early milestone.Achieving this integration, however,demands not just specific product func-tionality but a close partnership betweenthe LIMS vendor and the customer.

Traditionally, instrument integrationproducts were designed for single PC

Technological advances have ledto a proliferation of analytical datathat must be managed effectively.Colin Thurston, of ThermoElectron Corporation, discusseshow Laboratory InformationManagement Systems (LIMS)integration can help

InstrumentintegrationInstrumentintegration

Instrumentworkstations

SampleManagerInstrumentManager

Clients

Win32 instrumentintegration client

PDA device

Web client

SampleManagerLIMS server

Instrumentfile

Collector

Collector

Collector

Collector

RS-232

USB

Wireless, etc

XML (Web service)

Instrument data

LIMS server component

Data processing component Client access componentData collection component

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operation and struggle with today’s net-worked operations, leaving a clear needfor a more flexible, ‘scalable’ solution.Alternatives are emerging that employadvanced technology and architecturethat provide considerably more effi-cient and effective integration of LIMSwith laboratory instrumentation.

Instrument integration systemsacquire data automatically, with theprimary goal of eliminating errors intranscription and reducing the amountof time needed to manually write ortype results. Most systems in the phar-maceutical industry were implementedto ease compliance with regulatory pro-tocols, such as 21 CFR Part 11. Furtherdevelopment has meant that some sys-tems offer instrument connectivity thatinvolves very little coding to beinstalled and, more importantly, thefault tolerance necessary for 24-hourproduction environments.

Systems are usually capable of con-necting to most instruments that haveeither an output transmitting ASCII orthat can export data as an ASCII file.Also, each PC that runs the instrumentintegration software is able to connectmultiple instruments so that the num-ber of PCs that can be connected to theLIMS is effectively unlimited.

costly specificationsBut these types of solutions, oftentermed ‘thick client’ solutions by infor-matics vendors, tend to fall short in anumber of areas and can struggle, par-ticularly in laboratories in a highthroughput environment. They werenot originally designed to handle hugevolumes of data from the latest versionsof highly sophisticated instruments.

Scalability of hardware can alsorapidly become a problem. Each PCdedicated as an instrument workstationneeds a full system installation – capa-ble of data acquisition, processing andinterchange to the LIMS, while alsoproviding the client interface for theuser. This inevitably requires a costly,high specification machine at eachworkstation. Also, logistical problemsmay be encountered when integratinginstruments ‘down the wire’, in whichcase a high specification PC would needto be within the radius of the maximumcable run from each instrument.

In a laboratory with 20-30 instru-ments spread across a number of loca-tions, providing the administration andsecurity for all workstation PCs can bea major undertaking. Configurationsand upgrades of any individual ele-ment of the software can require a fullinstallation of the application, includ-ing the necessary configuration andsubsequent validation.

To cover for events such as hard diskfailure, an administrator would require

a back-up strategy for each workstation.Maintaining system security and elim-inating risk of data loss becomes a sig-nificant management challenge – occu-pying resources that could be moreproductively allocated elsewhere.

new approachesA more flexible and scalable instru-ment integration solution would incor-porate an architecture that separates thecollection and processing of instrumentdata into separate software compo-nents. In situations where high levels ofdata processing and modern, reliablenetworking are required, these softwarecomponents could be deployed in adistributed configuration. For manyglobal organisations, server-based dataprocessing is the preferable option.

A new approach to integrating LIMSwith instrument integration includes aPC that holds a series of instrument filecollectors with the workstation andinstruments. The function of these col-lectors is configured at the centralserver, which instructs each to look foreither a data file from a network or harddrive or a stream of data via an inter-facing port.

For example, the server can be con-figured to direct a collector to listen fora stream from a specific port, or to beready for a particular stream of dataand to stop at the termination of thestream. In addition, configuration of theserver controls the scheduling of thetransfer of the instrument data from thecollector. No processing whatsoeverneed be carried out at theinstrument workstation.

As analytical instru-ments evolve with newtechnology, collectors maybe added to support differ-ent types of data output.For instance, access to datavia XML (eXtensibleMarkup Language) basedfiles are becoming moreprevalent within pharma-ceutical QA/QC laborato-ries. Connecting theseinstruments to the LIMScould be as simple as installing a newcollector.

An architecture utilising a centralserver within a dedicated, secure, ITdepartment-controlled strong-room leadsto management efficiencies in a numberof areas. For example, it provides a singlelocation for updates, for configuration ofall parsing scripts (which extract the datafrom the instrument output) and all map-ping scripts (which correlate the datafrom the instrument to the correct fieldsin the LIMS).

The single central server also enablesthe back-up routines and security to becentrally administered and provides

the ability to build in hardware faulttolerance, redundancy and back-ups ata single location. In traditional archi-tecture for LIMS/instrument integrationarchitecture, all these critical issueswould need to be addressed at eachworkstation individually.

Taking PC theft as an example, in aworkstation-based application a fullinstallation of the application would berequired on a replacement PC plus afull configuration determining fromwhere data is to come and in what for-mat (instrument file, COM-basedinstrument, etc). Reconfiguration of allthe parsing and mapping scripts wouldalso be necessary.

This would either result in signifi-cant down time, or require laboriousmanual transcription of results whilewaiting for the instrument to be recon-nected.

Contrast this scenario against a solu-tion using scalable architecture, wherea replacement preconfigured PC can bequickly brought online. Only the col-lector component needs to be installed,along with any local parsing and map-ping configurations, for the system tobe up and running again.

Once the server is directed to the newcollector or series of collectors, instru-ment capture can be restored immedi-ately. Furthermore, savings can be madesince only low-grade PCs would be

required in this new architec-ture.

Modern LIMS/instrumentintegration solutions have beendesigned to address the data

management and security requirementsof today’s laboratory, such as compli-ance with 21 CFR Part 11. Organisationscan configure different roles and groupsfor individuals inside and outside thelab, assign appropriate functionality andsystem menu options to groups or spe-cific end-users, and prevent unautho-rised users from accessing specific areasof the system.

Integrated security, password protec-tion, audit trail and electronic signaturesallow multi-user access, while ensuringeach piece of information is accessibleonly by authorised personnel.

The trend for larger LIMS vendors �

Facing page: Diagramshowing how the LIMSserver component fitsin with data collectionand client access

Below: Moderninstrument integrationsolutions requireadvanced datamapping and parsingcapabilities to processdata from disparateinstrument types andmultiple vendors, thuseliminating the needfor bespokeinterfaces for eachinstrument system.

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is toward developing and implement-ing their own instrument integrationsolutions as alternatives to separatelysourcing third-party products. Thisapproach, taken by Thermo ElectronCorporation with its flagship LIMS,SampleManager, provides additionalvalue to existing and future installations.

A standard user interface is utilised

for all types and brands of instruments,providing consistency throughoutthe lab and the organisation, reduc-ing training requirements and accel-erating implementation. Automatingthe transfer of results from analyticalinstrumentation to SampleManageris eliminating manual typing ofresults with its associated transcrip-

tion errors. Now, even in very high throughput

environments, analytical informationfrom sophisticated instrumentation canbe delivered accurately and quickly tolaboratory management and otherauthorised decision-makers, increasingproductivity in the laboratory and low-ering the cost of ownership for LIMS. ■

contactColin G Thurston is LIMS productmanager, Thermo Electron Corp,based in Altrincham in the UK. T +44 161 942 3000info@thermoinformatics.comwww.thermo.com/informatics

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Microsoft .NET technology is a popular framework forscalable computing architecture and the ‘componentis-ing’ of software solutions. This technology offers a build-ing block approach to application development utilisingXML, enabling interconnectivity as well as integration to

larger applications over the Internet. The attributes of XML as a basisfor a data file standard have been well documented and it is enjoyingwidespread acceptance both as a data interchange and storage format,including within the regulated industries. XML is a public domain,platform-neutral data formatting standard. It offers an application-independent way of representing data, however rich, using plainASCII text.

These technologies provide a ‘future-proofing’ quality to theLIMS/instrument integration solution. New collectors, for example, can beembedded in the software by an instrument vendor, thereby simplifyingintegration with the LIMS.

Using architecture based on components rather than single larger appli-cations facilitates customisation of collectors without affecting the wholesolution. In a regulated environment, this offers significant savings in theextent of validation required to demonstrate compliance with GXPs.

By using Microsoft .NET within such an architecture, the instru-ment integration system can be presented to the user in different ways,via a Windows32 client or web pages. The ability for a chemist to con-figure instruments and review the status of instruments using PDAtechnology is another possibility.

By using a Web service interface to store analytical data in a LIMSas part of this architecture, the processing components can be isolatedfrom variations in multiple LIMS implementations; an important con-

sideration with large pharmaceutical manufacturers operating on aglobal basis. In brief, a Web service is simply an application that can bedelivered as a network service and integrated using standard Internettechnologies. Much of the strength of the Web services concept lies inthe fact that it combines a simple-to-understand format with provenand well-established communications technology.

Web services are built using a group of XML standards, thereby pro-viding complete platform independence. This allows an organisation todeploy the Web service on the server platform of its choice, and to use theWeb service from any application written in any programming language.

A Web service also allows for the reuse of existing business ruleswithin the LIMS. Organisations that have standardised on a LIMS fortheir laboratories will also have configured the LIMS differently forspecific labs – r&d and production environments, for example. Shouldone of the LIMS be upgraded in this situation, no changes would berequired to the instrument integration functionality. This simplifiesdeployment of new LIMS features, reduces validation efforts, andallows much greater flexibility than conventional LIMS deployments.

LIMS users, in fact users of any software application, will be famil-iar with how existing applications can mysteriously stop workingwhen they install a new application onto their PC. This is due to con-flict between the .dll files in the two applications.

By isolating applications, .NET eliminates this conflict. This meansthat when installing a new collector, for example, at the instrumentworkstation there need be no concern when using .NET component-based architecture.

This not only minimises impact on PC performance, but alsoreduces the amount of validation required in regulated environments.

Scalable computing architecture explained