LII:LIMS Selection Guide for ISO/IEC 17025 Laboratories/Resources for selecting and implementing informatics solutions
LIMSwiki provides a useful directory of LIMS vendors serving specific industries. If a vendor clearly indicates what industries they serve on their website, they are categorized under those industries. Otherwise, they are placed under the "General" category. However, "ISO/IEC 17025" isn't considered an industry for purposes of categorization; as we learned in Chapter 2, the testing, calibration, and sampling activities covered by ISO/IEC 17025 occur in a wide variety of industry contexts. As such, using such a directory will require you to examine vendors serving your industry and then investigate further how their LIMS touches all those requirements listed in the previous chapter.
For purposes of this guide, we simply list all known LIMS vendors as a base starting point. This may have little use to you, so you may also wish to consult the previously mentioned categorized directory for further granularity. The LIMS vendors and consultants listed below are directly pulled from LIMSwiki's maintained tabular listings of these types of entities. The professional section addresses trade organizations, conferences, and more. The last section further explores LIMSpec, which has been discussed in prior chapters.
4.1 LIMS vendors
NOTE: This listing represents all known active LIMS vendors. For a categorized listing of LIMS vendors by industry, see the listing of vendors by industry.
|Vendor||Key LIMS offering(s)||SaaS
|Key information||Additional notes|
|10BioSystems, LLC||LabCentral||Yes||United States|
|AAC Infotray AG||Limsophy LIMS||No||Switzerland|
|ABB Ltd.||Knowledge Manager||Yes||United States||Sold CCLAS LIMS to Datamine Software Ltd. in August 2019.|
|ABI-Health Technologies Pvt. Ltd.||ABI LIMS||No||India||LIMS is part of the SmartLabs platform.|
|ABS Systems, Inc.||PHIMS||No||United States|
|Adifo NV||BESTMIX LIMS||No||Belgium||Former product Laboras now seems defunct.|
|Advanced Solutions Accelerator SAS||100 lims||No||France|
|Advanced Technical Software||uniLIME||No||Austria||Former product q/LIME seems no longer supported.|
|Advanced Technology Corp.||VADDS, VETSTAR||No||United States|
|Agaram Technologies Pvt. Ltd.||Qualis LIMS||Yes||India||Demonstration videos|
|Agile Frameworks, LLC||MetaField||Yes||United States||Demonstration videos||A field information management system for architecture,|
engineering, and construction that contains a full LIMS module
|AgileBio||LabCollector||Yes||United States||Pricing and demonstration videos|
|Agilent Technologies, Inc.||iLab Operations Software, SLIMS||Yes||United States||Demonstration videos||Agilent acquired the iLab core facility management software in 2016.|
Agilent acquired Genohm SA in May 2018.
|AINZ Corp.||LabFlow||Yes||United States||Pricing and demonstration videos||Cannabis-oriented LIMS; former product was PharmWare.|
|AiZen Algo Pvt. Ltd.||LabZen||No||India|
|Alchemy Cloud, Inc.||Alchemy||Yes||United States||Demonstration videos||Integrated LIMS+ELN predictive chemistry platform|
|Alcor SPRL||CI-Master, LabTec||No||Belgium|
|Alpha Technologies US, LP||Enterprise||No||United States|
|Ambidata Digital Innovation Solutions & Consulting, Lda.||LabWay-LIMS||No||Portugal|
|American Technical Services, Inc.||MOX||No||United States||"Laboratory workflow and [metrology] management system"|
with LIMS module
|Analytical Information Systems, Ltd.||AIS LIMS||No||United Kingdom|
|Aquatic Informatics, Inc.||AQUARIUS||Yes||Canada||Demonstration videos||Not marketed as a LIMS, but software suite has|
extensive LIMS functionality.
|ASM Soft SL||asmLIMS||No||Spain|
|Assaynet Inc.||Assaynet LIMS||No||Canada||Demonstration videos||Previous name for LIMS2010 was LIMS2003.|
|Asterian, LLC||ArgoLIMS||Yes||United States||See the LIS vendor page for QuikLIMS.|
|Asystance B.V.||AlisQI LIMS||Yes||Netherlands||Demonstration videos|
|ATGC Labs, LLC||ActiveLIMS||No||United States|
|Aurora Systems, Inc.||VisuaLab||No||United States|
|Autoscribe Informatics, Inc.||Matrix Gemini, Matrix Express||Yes||United States||Pricing and demonstration videos||North American distributor/support team was|
Zumatrix, Inc. until it was absorbed into new
entity Autoscribe Informatics, Inc.
|Bassetti France SAS||TEEXMA LIMS||No||France|
|Batalyse GmbH||Mind||No||Germany||Demonstration videos|
|Baytek International, Inc.||cBLISS||Yes||United States||Product line changed in summer 2017 with introduction of cBLISS.|
|Beijing Bio-LIMS Soft Co. Ltd.||Bio-LIMS||No||China|
|Bentley Systems, Inc.||KeyLAB||No||United States||Pricing and demonstration videos||Acquired Keynetix Ltd. and KeyLAB in 2019.|
|BGASoft, Inc.||LIMS ABC||Yes||United States|
|Bika Lab Systems (Pty) Ltd.||Bika LIMS||Yes||South Africa||Pricing||Also available at SourceForge.net under GPL.|
|Bio-Analytical Technologies Pvt. Ltd.||BioClinical||No||India|
|Bio-ITech BV||eLABInventory, eLABJournal||Yes||The Netherlands||Pricing and demonstration videos||Neither is a true traditional LIMS; Inventory is a sample manager|
and Journal is an ELN with the features of Inventory. However, both
have LIMS-like features.
|BioData Inc.||Labguru||Yes||United States||Demonstration videos||Labguru replaced LabLife and BioKM on December 5, 2011.|
Became an ELN+LIMS platform in late 2022.
|BioFortis, Inc.||Labmatrix||No||United States|
|BioInfoRx, Inc.||mLIMS||Yes||United States||Pricing and demonstration videos||Animal colony management LIMS|
|Biomatters Ltd.||Geneious||No||New Zealand||Pricing and demonstration videos|
|Biomed Systems Ltd.||LABA||Yes||England||Pricing and demonstration videos||Biotechnology and biobanking LIMS|
|Bit Wave Solutions Ltd.||Labsols LIMS||Yes||United Kingdom|
|Blaze Systems Corporation||BlazeLIMS||Yes||United States||Pricing and demonstration videos|
|Bode Cellmark Forensics, Inc.||BodeLIMS||No||United States|
|Brooks Automation, Inc.||FreezerPro, Limfinity||Yes||United States||Pricingand demonstration videos||Sample management solutions + LIMS|
|Broughton Software Ltd.||LabHQ||Yes||United Kingdom||Pricing and demonstration videos||Was formerly SkySource Ltd.|
|Bruker Corporation||SampleTrack||No||United States|
|BTLIMS Technologies||BTLIMS, ALPACA LIMS||Yes||United States|
|Bureau Conseils et Services SCRL||AQ Manager LIMS||Yes||Belgium||Pricing and demonstration videos|
|Bytewize AB||O3 LIMS, O3 LIMSXpress||Yes||Sweden||Pricing and demonstration videos|
|Caliber Technologies Pvt. Ltd.||CaliberLIMS||Yes||India|
|Cannabliss New England, LLC||CannabLIS||Yes||United States||Cannabis LIMS|
|Capstone Technology Corporation||dataPARC||No||United States|
|Cerebrum Corporation||LABdivus||Yes||United States|
|Cargotrader, Inc.||Cargotester.com||Yes||United States|
|Carobar Business Solutions, LLC||reLIMS||Yes||United States|
|CC Software, LLC||Confident Cannabis LIMS||No||United States||Demonstration videos|
|CellPort Software, LLC||CellPort Cell Culture Suite||Yes||United States||Demonstration videos|
|Clinical Systems Ltd.||ClinAxys II||No||United Kingdom|
|CliniSys Group Limited||Clinisys WinPath||No||United Kingdom||Part of the Clinisys brand of companies.|
|Clinisys NV||Clinisys GLIMS, GLIMS Genetics, and DaVinci||No||Belgium||Was MIPS NV until September 2022.|
Part of the Clinisys brand of companies.
|CliniSys, Inc.||Clinisys ApolloLIMS and SQ Lab||No||United States||Renamed from Sunquest Information Systems, Inc. on May 31, 2022.|
Part of the Clinisys brand of companies.
|CloudLIMS.com, LLC||CloudLIMS, FreeLIMS||Yes||United States||Pricing and demonstration videos|
|Clyde Computing Ltd.||Q-SYS LIMS||No||United Kingdom|
|Codon Software Private Limited||Codon LIMS||No||India|
|Columbia Energy & Environmental Services, Inc.||OmniLIMS||No||United States|
|CompuDrug International, Inc.||Laboratory Manager Plus||No||United States|
|Computing Solutions, Inc.||LabSoft LIMS||No||United States|
|Comsense Datasystems of Australia||ComLIMS||No||Australia|
|Condition Monitoring International, LLC||LabTrak||No||United States|
|Contec Group International Ltd.||MADCAP||Yes||New Zealand|
|Cosine Consultants Ltd.||Fission LIMS||No||Cyprus|
|CSMS Sp. z o.o.||CS-17 LIMS||No||Poland|
|Dassault Systèmes SA||BIOVIA Lab Management||No||France||Demonstration videos||Dassault acquired Accelrys, Inc. on April 29, 2014.|
|Data Systems Integration Group, Inc.||RevolutionDx||Yes||United States|
|Data Unlimited International, Inc.||Starfruit GeneTell, IdentiTrack, and Toxicology||No||United States|
|Datamine Software Ltd.||CCLAS EL and CCLAS 6||Yes||United Kingdom||Demonstration videos|
|Dataworks Development, Inc.||Freezerworks||No||United States||Demonstration videos|
|Dedalus Healthcare Ltd.||Dedalus LIMS||Yes||United Kingdom||Pathology LIMS|
|Deutsche Telekom Healthcare Solutions Netherlands B.V.||LMS, SymPathy Lifecare||No||Netherlands||Acquired Finalist Software Noord Nederland C.V.|
and LMS in January 2019.
|DHC Dr. Herterich & Consultants GmbH||SAP QM||No||Germany|
|dialog EDV Systementwicklung GmbH||diaLIMS||No||Germany|
|Diversity Arrays Technology Pty. Ltd.||DArT LIMS||No||Australia||Demonstration videos|
|Dorner GmbH & Co. KG||B/Lab, i/med Genetics, i/med Hygiene,
|Drishti-Soft Solutions Pvt. Ltd.||cLIMS||No||India|
|Dynamic Databases, LLC||limsExpress||Yes||United States||Demonstration videos|
|E-BiOnary Technologies Pvt. Ltd.||e-BiOnary A, C, M, and D||Yes||India||Demonstration videos|
|EffiChem s.r.o.||EffiChem||Yes||Czech Republic||Demonstration videos|
|Elysia-raytest GmbH||BioTrax||No||Germany||Specializes in radiopharmaceutical LIMS.|
|ElmTree Systems, LLC||ElmTree System||No||United States|
|Elmwood Solutions, Inc.||Pure Harvest||Yes||United States||LIMS-like seed lab software|
|Enable IT Solutions Pvt. Ltd.||Ensō-LIMS||No||India||Demonstration videos|
|EthoSoft, Inc.||X-LIMS||No||United States||Pricing|
|Eusoft Srl||EuSoft.Lab||Yes||Italy||Demonstration videos|
|ExeVision, Inc.||Materials Management System||Yes||United States|
|Fink & Partner GmbH||[FP]-LIMS||No||Germany||Demonstration videos||Former product was [Dia]|
|Forney, LP||ForneyVault||Yes||United States||Pricing and demonstration videos|
|Frontier Science & Technology Research Foundation, Inc.||LDMS||Yes||United States||Demonstration videos|
|Future Technologies, Inc.||DNA LIMS||No||United States|
|Genesis MicroSystems, Inc.||LAB-2000||No||United States|
|Genetic Technologies, Inc.||eDNA LIMS||No||United States||Pricing|
|Genetrics, Inc.||GEN-LIMS||No||United Arab Emirates|
|Genial Genetic Solutions, Ltd.||iGene, Shire||No||United Kingdom|
|Genosity, Inc.||Integrated Genomic Toolkit||Yes||United States||Genomics platform with a LIMS|
|GoInformatics, Inc.||GoLIMS||Yes||United States||Demonstration videos|
|GoMeyra Corporation||GoMeyra LIMS||Yes||United States||Demonstration videos|
|GQM mbH||Qualifax LIMS||No||Germany|
|GTS Systems Private Limited||GLab360, LabExpress||Yes||Egypt|
|GUS LAB GmbH||LABbase, LABS/Q LIMS||No||Germany||Result of merger between Blomesystem GmbH and iCD System GmbH on May 1, 2023.|
|H&A Scientific, Inc.||SLIM||No||United States||Screenshots|
|Hach Company||Hach WIMS||Yes||United States, Germany||Demonstration videos|
|Harris Systems USA, Inc.||Forensic Advantage||Yes||United States||Placed under Harris' Caliber Public Safety division.|
|i2D Solution, Inc.||i2DS LIMS||No||United States|
|Illumina, Inc.||BaseSpace Clarity LIMS, Illumina LIMS||Yes||United States||Demonstration videos|
|In-QM-Team Software GmbH||WinLaisy||No||Europe||Development taken over from inray Industriesoftware GmbH|
in March 2019.
|Indusoft OOO||I-LDS LIMS||No||Russia||Demonstration videos|
|Infomed Kouvatsos Theodoros Ltd.||Lab@link||No||Greece|
|Infonote Datasystems Ltd.||Infonote LIMS||Yes||United States|
|Information Management Services, Inc.||BSI, SEER*DMS||Yes||United States||Pricing and demonstration videos|
|InfoTrak Pty. Ltd.||Oil Commander||No||Australia||Previous product name was InfoTrak Oil.|
|Instem LSS Limited||Provantis||Yes||United Kingdom|
|Instrumentos Científicos SA||NevisLIMS||Yes||Spain||Demonstration videos|
|IntaForensics Ltd.||Lima Forensic Case Management||No||United Kingdom||[[[IntaForensics Ltd.#Demonstration videos and other media|Demonstration videos]]|
|Integrated Software Solutions Ltd.||OMNI-Lab||No||Australia||Absorbed Point of Care Solutions Pty. Ltd. and v-Lab in 2020.|
|INTEGRIS LIMS GmbH||iLIMS||No||Germany||Pricing and demonstration videos||Changed company name from CSS LIMS GmbH in March 2017.|
|Interactive Software Limited||Achiever Medical LIMS||Yes||United Kingdom|
|Interactive Technology Services, LLC||LIMS IAL||Yes||United States|
|Interpec Corporation||INQAS, INTRACES||No||United States|
|InterSystems Corporation||TrakCare Lab||No||United States||Demonstration videos|
|InVita Healthcare Technologies, Inc.||STACS Casework, STACS Database||Yes||United States||Acquired from STaCS DNA Inc. in May 2021.|
|iVention BV||iVentionLES||Yes||Netherlands||Demonstration videos||Marketed as a laboratory execution system with LIMS,|
ELN, and SDMS functionality
|J Street Technology, Inc.||J Street LIMS||No||United States||Pricing||Formerly MSC-LIMS by Mountain States Consulting, LLC.|
|Jeganee Technologies Pvt. Ltd.||Laboratory-On||Yes||India|
|JusticeTrax, Inc.||LIMS-plus||No||United States||Pricing|
|Khemia Software, Inc.||Omega 11 LIMS||No||United States||Screenshots|
|Kriti Microsystems Pvt. Ltd.||Kriti LIMS||No||India|
|KVANT spol. s r.o.||Evidence||No||Slovakia|
|L7 Informatics, Inc.||L7 ESP||No||United States||Demonstration videos||Enterprise science platform/workflow engine w/ a LIMS|
|Lab Iconics Technologies LLP||Lab Iconics LIMS||Yes||India|
|LabCloud, Inc.||LabCloud||Yes||United States|
|Labforward GmbH||Labregister||Yes||Germany||Integrates with company's ELN Labfolder|
|Labii, Inc.||Labii ELN & LIMS||Yes||United States||Pricing and demonstration videos||Combination ELN + LIMS|
|LabKey Corporation||LabKey Biologics LIMS||Yes||United States||Pricing and demonstration videos|
|LabLite, LLC||LabLite SQL LIMS||No||United States||Pricing|
|LabLogic Systems Limited||Debra, PETra||No||United Kingdom||Demonstration videos|
|LabLynx, Inc.||ELab||Yes||United States||Pricing and Demonstration videos|
|LabMaster.pl Sp. z o.o.||LabMaster LIMS||Yes||Poland|
|Labmin (Pty) Ltd.||Labmin, Labmin Lite||Yes||South Africa||Demonstration videos|
|LabPro 2000 Ltd.||eQual||Yes||New Zealand|
|Labs Division SL||OraLims 2000i and 3.0||Yes||Spain||Demonstration videos|
|Labsoft Tecnologia Ltda.||myLIMS||Yes||Brazil||Demonstration videos||Not to be confused with Odysis SA's myLIMS product.|
|Labstudio (Pty) Ltd.||Labstud.io LIMS||Yes||South Africa||Pricing and screenshots|
|LABTrack, LLC||LABTrack LIMS||Yes||United States||EKM Corporation was previously a distributor of LABTrack.|
|LabVantage Solutions, Inc.||LabVantage 8||Yes||United States||Pricing and demonstration videos||Products formerly called SAPPHIRE and SQL*LIMS.|
|LabWare, Inc.||LabWare LIMS, LabWare GROW||Yes||United States||Pricing and demonstration videos|
|Labworks, LLC||Labworks||No||United States||Bought LABWORKS from PerkinElmer Inc. in May 2016.|
|Lenava Engineering Group Ltd.||Lenava LIMS||Yes||United Kingdom|
|LETEC SARL||Tetraed LIMS||No||France|
|Lex Software Solutions||Manage!||Yes (customer request)||Turkey||Screenshots|
|LGC Limited||Kraken||No||United Kingdom|
|LIMS at work GmbH||Labmatica LIMS||No||Germany|
|Limseo SARL||Solution Laboratoire||No||France|
|LIMSey, LLC||LIMSey||No||United States|
|Locasoft SARL||LIMS.FR||Yes||France||Demonstration videos||Product changed names in 2019 from Lims.net to LIMS.FR.|
|Logiq Innovations, Inc.||LabPlus||No||Canada||LabPlus formerly a product of LabPlus Technologies.|
|LogicaSoft SPRL||Odoo LIMS||Yes||Belgium||A LIMS built on open-source Odoo ERP|
|LTech Australia Pty. Ltd.||Lims1||No||Australia|
|Lyons Information Systems, Inc.||LLMS||Yes||United States|
|M-Tech International, Inc.||CAT2 LIMS||No||United States|
|Malvern Panalytical BV||SPARCS||No||Netherlands||Previously known as PANalytical BV.|
|MAQSIMA GmbH||MAQSIMA LAB+||No||Germany|
|Materials.Zone Ltd.||Materials Informatics Platform||No||United States||Materials testing platform with LIMS-like functionality|
|Mci IT Pty. Ltd.||Cloud Solutions Suite||Yes||South Africa||Pricing and demonstration videos|
|MEDEORA GmbH||BioArchive||Yes||Germany||Pricing and demonstration videos||Biobanking LIMS|
|Medpace, Inc.||ClinTrak Lab||No||United States||Clinical research LIMS|
|Megaware, Inc.||LIAS||No||United States|
|Methodiq, LLC||custom LIMS development||No||United States|
|ML Consulting Technologies, LLC||WeLIMS||Yes||United States||Pricing and demonstration videos||Free quality control LIMS for small labs|
|Motto Systems Pvt. Ltd.||GMPPro LIMS||Yes||India||Demonstration videos|
|Mukon Informatics (Pty) Ltd.||Skylims||No||South Africa||Formerly Mukon CC. LIS marketed as a LIMS.|
|National Agribusiness Technology Center||USALIMS||No||United States||Pricing|
|National Cancer Institute||caLIMS||No||United States||Pricing|
|Nexactly AI Solutions Pvt. Ltd.||Nexactly LIMS||No||India|
|Nexix, Inc.||Nexix LIMS||Yes||Canada||Designed for PCR|
|Nippon Control System Corporation||SimpDoc||No||Japan||Discontinued SimpLabo in May or June 2018.|
Still offering SimpDoc, per company.
|Oasis Infotech Pvt. Ltd.||EnviroLIMS EWM, LIMZ-RD,
OasisLIMS, True-LIMZ CTL
|Ocimum Biosolutions Ltd.||Biotracker LIMS||Yes||India|
|Odysis SA||myLIMS||No||Switzerland||Not to be confused with Labsoft Tecnologia Limitada's myLIMS product.|
|Online LIMS Canada Limited||OnLIMS||No||Canada|
|OnQ Software Pty. Ltd.||QLIMS||Yes||Australia|
|Open-source software solution||Bika LIMS||N/A||N/A||See Bika Lab Systems (Pty) Ltd. for more info.|
|Open-source software solution||caLIMS||N/A||N/A||See National Cancer Institute for more info.|
|Open-source software solution||ClinViro||N/A||N/A||More information found on [project page].|
|Open-source software solution||GNomEx||N/A||N/A||More information found on SourceForge.net.|
|Open-source software solution||GNU LIMS||N/A||N/A||More information found on the project page.|
|Open-source software solution||LAMA||N/A||N/A||More information found on the project website.|
|Open-source software solution||Leaf LIMS||N/A||N/A||More information found on the project website.|
|Open-source software solution||MetaLIMS||N/A||N/A||More information found on the project website.|
|Open-source software solution||Open-LIMS||N/A||N/A||More information found on the project website.|
|Open-source software solution||openBIS||N/A||N/A||More information found on the project website.|
|Open-source software solution||OpenELIS||N/A||N/A||More information found on the project website.|
|Open-source software solution||OpenSpecimen||N/A||N/A||More information found on the Krishagni Solutions Pvt. Ltd. page.|
|Open-source software solution||Screensaver HTS LIMS||N/A||N/A||More information found on SourceForge.net.|
|Open-source software solution||SMITH||N/A||N/A||More information found on Bitbucket.|
|OPTIMAL SYSTEMS GmbH||enaio Laboratory Content Center||No||Germany|
|Oracle Corporation||Oracle Health Sciences
Clinical Development Analytics
|Ovation.io, Inc.||Ovation LIMS||Yes||United States||Demonstration videos||Company and product have undergone many name changes,|
with "Ovation" the latest.
|Oy Fision Ltd.||Broadsight LIMS||No||Finland|
|PDS Group Holding AG||Ascentos||Yes||Switzerland||Former products were PathData, ReproData, and ToxData.|
|pdv-software GmbH||pdv-lims 3||No||Germany|
|Persistent Systems Ltd.||ChemLMS||No||India||Acquired from Agilent.|
|Pharmaceuticals Systems International, LLC||PSI||Yes||U.S.||Pricing and demonstration videos||Cloud-based application suite that includes LIMS|
|PiControl Solutions, LLC||PiLims||No||United States|
|Polisystem Informatica Srl||Analisi||No||Italy|
|Pondpol Group||The rapid family of LIMS||No||Thailand||Five LIMS-like solutions covering multiple industries|
|Porter Lee Corporation||Crime Fighter BEAST||No||United States|
|Process Solutions Canada Limited||LDMS||No||Canada|
|Prog4biz Software Solutions Ltd.||BookitLab||Yes||Canada|
|Progeny Genetics, LLC||Progeny Clinical||Yes||United States||Pricing||Some pricing available for Clinical.|
|Promadis Pty. Ltd.||Caseman||No||Australia|
|Promium, LLC||Element LIMS||Yes||United States||Pricing and demonstration videos|
|PRYM-SOFT Sp. z o.o.||CleverLAB, PureLAB||Yes||Poland|
|PT Digita Scientia Indonesia||OrbitaLIMS||No||Indonesia|
|QBench, Inc.||QBench||Yes||United States||Demonstration videos||Transferred from Junction Concepts, Inc. in August 2022.|
(Source: Personal correspondence)
|QDA SOLUTIONS GmbH||QDA LIMS||No||Germany|
|Qualitype GmbH||Abetter LIMS||No||Germany|
|Quality Systems International Corporation||WinLIMS||Yes||United States|
|Quartz Imaging Corporation||Quartz CH-, FA-, and RE-LIMS||No||Canada|
|Raddec International Ltd.||Raddec-LIMS||No||United Kingdom||Demonstration videos|
|Realistic Computing, Inc.||eData Specialty LIMS||No||United States|
|Reston Stable Isotope Laboratory||LIMS for Lasers,
LIMS for Light Stable Isotopes
|No||United States||Pricing||The RSIL is part of the U.S. Geological Survey.|
|Revol Software Solutions, LLC||Revol LIMS||Yes||United States||Pricing and demonstration videos|
|RHAPSODY Software Solutions GmbH||RHAPSODY LIMS||No||Germany||Officially changed name from Softwaresysteme Keeve GmbH in February 2018.|
|RJ Lee Solutions, LLC||THEMIS||No||United States|
|RockStep Solutions, Inc.||Climb||Yes||United States||Demonstration videos|
|S.G. Systems, LLC||V5 Traceability||No||United States||Manufacturing traceability software system with a LIMS module|
|Sapio Sciences, LLC||Sapio LIMS||Yes||United States||Demonstration videos|
|Satya Sistemas Ltda.||Flux2||No||Brazil|
|Scispot.io, Inc.||Scispot||No||United States||Biotech platform with some LIMS- and ELN-like functionality|
|Scigilian Software, Inc.||Scigilian||Yes||United States|
|ScienTek Software, Inc.||iStability LIMS||No||United States||LIMS designed for pharmaceutical stability testing programs|
and stability test management
|Semaphore Solutions, Inc.||Labbit, custom LIMS development||No||Canada|
|Sempai Consulting Ltd. & Co. KG||scarabPLUS||No||Germany||A pharmaceutical ERP that fully integrates a LIMS|
|Siemens AG||Formulated Product Design, SIMATIC IT Unilab||No||Germany|
|Sigmen Technologies Solutions Pvt. Ltd.||Sigma LIMS||No||India|
|Simploud Limited||Simplab||No||Israel||Pricing and demonstration videos||Salesforce-based LIMS|
|SLCLAB Informática SL||ALFA21, Zendo LIMS||Yes||Spain||Pricing and demonstration videos|
|Sofcom (Private) Limited||Spectrum||No||Pakistan|
|Soft Computer Consultants, Inc.||SoftLIMS||Yes||United States|
|Software for Life Sciences BV||LabScores||No||Netherlands||Demonstration videos|
|Software Point Oy||LabVantage Medical Suite,
Enterprise, and Express
|Yes||Finland||Acquired by LABVANTAGE in April 2011. C5 LIMS was renamed to|
"LABVANTAGE Medical Suite" in December 2012. Former products:
TasteBOSS and WilabLIMS
|Sorenson Forensics, LLC||eDNA LIMS||No||United States||Forensic LIMS|
|SpecPage AG||SpecLIMS||No||Switzerland||Previously known as Object Solutions Software AG.|
|Spectra QEST Australia Pty. Ltd.||QESTField, QESTLab||No||Australia|
|StackWave, LLC||StackWave Affinity LIMS||Yes||United States|
|Stanford University School of Medicine||MendeLIMS||No||United States|
|STARLIMS Corporation||STARLIMS||Yes||United States||Pricing and demonstration videos||Formerly Abbot Informatics Corporation.|
|Stelsel Software Technologies Pvt. Ltd.||NABL LIMS||No||India|
|Suvarna Technosoft (P) Ltd.||Suvarna LIMS||No||India||Clinical LIMS|
|TechWare Incorporated||Logbook Discovery,
|Telesphorus Consulting Ltd.||gemLIMS||Yes||United Kingdom|
|TeselaGen Biotechnology, Inc.||TeselaGen Operating System||Yes||United States||Pricing and demonstration videos||Bioinformatics platform with a LIMS module|
|The Edge Software Consultancy Ltd.||BioRails LIMS||Yes||United Kingdom||Pricing and demonstration videos|
|Thermo Fisher Scientific||Core LIMS, Nautilus, SampleManager, Watson||Yes||United States||Demonstration videos|
|Third Wave Analytics, Inc.||Lockbox LIMS||Yes||United States||Pricing and demonstration videos|
|Title21 Health Solutions, Inc.||Cellular Therapy Solution||No||United States||Demonstration videos||A LIMS with a focus on cellular therapy|
|Trace First Ltd.||CoreOne for Labs||Yes||Ireland|
|TraxStar Technologies, Inc.||QATrax LIMS||No||United States||Demonstration videos|
|Tribal Software, Inc.||LIMS Lyte, Tribal-LIMS||No||United States|
|Triestram & Partner GmbH||lisa.lims||No||Germany|
|Trilogy Group Limited||TAPS||No||United Kingdom|
|TRUST Infotech Electronics, LLC||TRUST LIMS||No||United Arab Emirates|
|TQ Technology Pvt. Ltd.||TQLIMS||No||India|
|Uncountable, Inc.||Uncountable||Yes||United States||Demonstration videos||LIMS- and ELN-like platform for chemical R&D|
|U.S. EPA||Scribe||No||United States||Pricing|
|up to data sales and services GmbH||up2Lims||No||Germany|
|Valdata Systems USA, Inc.||Chemical Management System||Yes||United States||Demonstration videos||Suite of modules, including a LIMS, for manufacturing|
|Veeva Systems, Inc.||Vault LIMS||Yes||United States|
|Venture Development, LLC||GoRev||Yes||United States||Health information system with LIMS/LIS|
|Verisis A.S.||CLIMS||No||Turkey||Forensic LIMS|
|VertiQ Software, LLC||CME-LIMS||No||United States||Forensic LIMS|
|Vette EDV-Beratung & Entwicklung GmbH||TransGraph||No||Germany||Quality management software with a LIMS module|
|Waters Corporation||NuGenesis 8||No||United States||Pricing and demonstration videos||NuGenesis 8 is a data management and workflow package|
of applications, including NuGenesis Sample Management.
|Wavefront Software, Inc.||Wavefront LIMS||Yes||United States||Demonstration videos|
|WESTcom Logiciels et Services SARL||ARES||No||France|
|WireWorks West, Inc.||FermWorks||No||United States||Formerly operated as Jova Solutions Inc.|
|Wixon and Cross, LLC||LIMFinite||Yes||United States|
|Wolfe Information Systems, Inc.||Wolfe LIMS||No||United States||Pricing|
|Xybion Corporation||Labwise XD, Pristima XD||Yes||United States||Pricing and demonstration videos||Pre-clinical LIMS solutions|
|Yokogawa Electric Corporation||OpreX, CIMVisionLIMS||No||Japan|
|Yro Systems Pvt. Ltd.||MocDoc LIMS||No||India|
|Yullin Technologies Co., Ltd.||LabMate Enterprise||No||South Korea|
These consultancies seem to focus primarily on helping others plan, choose, and implement an informatics system for the laboratory, though they may offer other services to laboratories, such as computer system validation (CSV), project management, and workflow development. (The location represents the entity's headquarters.)
|Vendor||Headquarters||Key services||Services page|
|A Byte of Advice, Inc.||Fairfield, IL, U.S.||"We provide project management, system development, code modification, support and training";
experience with LabVantage and PerkinElmer products
|A2LA Workplace Training||Frederick, MD, U.S.||LIMS, quality management systems, regulatory compliance assessments, process and risk management, etc.||Services page|
|ABB Ltd.||Zurich, Switzerland||Provides an expansive set of services.||Services page|
|Accenture PLC||Dublin, Ireland||Laboratory informatics, LIMS, LIS, ELN, data analytics, managed services, etc.||Services page|
|AKKA Technologies Group||Brussels, Belgium||Information technology, engineering, clinical data management, regulatory affairs and compliance, etc.||Services page|
|Astrix, Inc.||Red Bank, NJ, U.S.||"Astrix’s core competency is to assist organizations in the development and implementation of data
management strategies to enhance the collection, processing, analysis and reporting of scientific data."
|Avellana Learning Oy||Vantaa, Finland||LIMS, LIS, and ELN implementation; open-source software implementation; software validation; quality control||Services page|
|BC Solutions, LLC||Phoenix, AZ, U.S.||LIS implementation, interface testing and validation, project management and consulting,
|BGASoft, Inc. dba LIMS ABC||Fort Lauderdale, FL, U.S.||Business analysis, lab process improvement, enterprise and cloud architecture, LIMS implementation, etc.||Services page|
|Bika Lab Systems (Pty) Ltd.||Western Cape, South Africa||LIMS requirement analysis, design, customization, configuration, and testing; training; project management, etc.||Services page|
|Bottom Line Consulting, LLC||Endwell, NY, U.S.||Labware products, user requirements specifications, vendor selection, project management||Services page|
|Brevitas Consulting, Inc.||Sacramento, CA, U.S.||Labware products, LIMS implementation; project management; quality assurance, etc.||Services page|
|C4 Database Management, Inc.||Port Orchard, WA, U.S.||LIS administration, LIS integrity, data integrity, database installation and migration||Services page|
|Chemtech Servicos de Engenharia e Software Ltda.||Rio de Janeiro, Brazil||Manufacturing execution systems, SCADA, automation, cyber security, etc.||Services page|
|Clarity Compliance Solutions Limited||Chepstow, Wales||LIMS, system validation, data integrity, process mapping, vendor selection, etc.||Services page|
|Clarkston Consulting||Durham, NC, U.S.||LIMS, data integrity, process mapping, vendor selection, quality management, project management etc.||Services page|
|Clevr||Newstead, QLD, Australia||Laboratory process and technology consultations, custom LIMS development||Services page|
|Clinical Lab Consulting, LLC||Dublin, OH, U.S.||Provides a wide range of services "to all types of clinical laboratories including governmental, academia,
hospital, reference and physician office laboratories."
|Clinical Laboratory Consultants dba Medical Source||Marietta, GA, U.S.||"Medical Source offers experience, guidance, and unmatched expertise in the physician office and
independent reference laboratory."
|Cosine Consultants Ltd.||Strovolos, Cyprus||Software customization, data management system consulting, Fission LIMS, etc.||Services page|
|CSols, Inc.||Newark, DE, U.S.||Laboratory informatics strategic services, ELN and LIMS implementation, computer system validation, and
laboratory vendor-specific technologies
|Digital Lab Consulting Ltd.||London, U.K.||LIMS, LIS, and ELN implementation; computer system validation; business case development;
requirements definition; project management; vendor selection; etc.
|e-Science Solutions Ltd||Whittington, U.K.||Information technology, business case development, requirements definition, vendor selection, etc.||Services page|
|EM2 Solutions, Inc. dba Labtopia||Houston, TX, U.S.||Laboratory informatics strategic services, LIMS implementation, computer system validation,
quality management systems, training, and staffing
|Engineering Industries eXcellence||Chicago, IL, U.S.||LIMS selection, implementation, and change management; lab automation; and more||Services page|
|Excelra||Boston, MA, U.S.||LIMS and ELN selection, implementation, and change management;
workflow optimization; program and project management;
data migration and integration
|EquixTech||Madrid, Spain||LIMS selection, implementation, and change management; manufacturing execution systems;
automation; industrial internet of things
|Fructeam SARL||Paris, France||eLearning tools, clinical trial management systems, LIMS, ELN, SDMS, SAP||Services page|
|HPFM, Inc.||Pacifica, CA, U.S.||LIMS selection, implementation, and change management; computer system validation; quality
management systems, etc.
|iConnect Consulting, Inc.||San Francisco, CA, U.S.||LIMS implementation and validation; computer system validation; HL7 electronic communication, training||Services page|
|IMCOR GmbH||Filderstadt, Germany||LIMS selection and implementation, computer system validation, business process analysis and optimization||Services page|
|InfoWiz||Anyang, Gyeonggi, South Korea||LIMS, LES, ELN, SDMS, and quality management system selection and implementation; system integration||Services page|
|Kainos Healthcare Solutions, LLC||Richmond, VA, U.S.||Laboratory informatics, LIMS, LIS, EHR, EMR, quality control, procurement and implementation,
custom development; they also offer a laboratory quality management solution, eQCo
|Kalleid, Inc.||Cambridge, MA, U.S.||"We work across the value chain in R&D, clinical and quality areas to deliver support services for software
implementations in highly complex, multi-site organizations."
|Lab Insights, LLC||Carlsbad, CA, U.S.||Laboratory informatics, computer system validation, vendor assessment, HIPAA audits and training,
quality assurance, process improvement, etc.
|LabMetrics, LLC||Ishpeming, MI, U.S.||Laboratory informatics, automation, instrumentation, compliance and auditing, quality assurance, etc.||Services page|
|Laboratory Advisory Bureau, LLC||McAllen, TX, U.S.||Clinical laboratory informatics, LIS, quality assurance, compliance and auditing, workflow management, etc.||Services page|
|Laboratory Systems Consulting||Celbridge, Ireland||Laboratory and scientific informatics, 21 CFR Part 11, project management, etc.||Services page|
|LIMeS Lab Support||Netherlands||Laboratory informatics, LIMS, LES, ELN, SDMS, lab automation||Services page|
|LIMS4U||Bedworth, England||Laboratory informatics, LIMS||Services page|
|LIMSCON||Vienna, Austria||Laboratory informatics, LIMS, ELN, CDMS, document management, training, project management,
computer system validation, etc.
|LUFC LabConsultants||Mierlo, The Netherlands||Laboratory informatics, LIMS, ELN, CDMS, SDMS, vendor selection, computer system validation,
workflows, project management, lab management, etc.
|Nichols Management Group Ltd.||York Harbor, ME, U.S.||Clinical laboratory informatics, system assessment, implementation, and integration;
project management; workflow management, etc.
|NNIT A/S||Søborg, Denmark||Laboratory informatics; system assessment, implementation, and integration;
system validation; project management; workflow management; etc.
|Nous Labautomation Support||Mariaheide, Netherlands||Laboratory process, automation, and regulation assistance; project management;
LIMS, ELN, CDS, and document management system implementation
|NXG Group, Inc.||Chennai, India||Laboratory informatics, LIMS, testing and validation, system integration management,
business consulting, etc.
|Orbis Labsystems Ltd.||Dublin, Ireland||Laboratory informatics, LIMS, quality assurance, system integration management, automation, etc.||Services page|
|OSTHUS GmbH||Aachen, Germany||Laboratory informatics, LIMS, system integration management, business consulting, etc.||Services page|
|prime4services GmbH||Karlsruhe, Germany||LIMS, project management, vendor selection, quality management and validation, etc.||Services page|
|PQE Group - Europe||Florence, Italy||Laboratory informatics, LIMS, laboratory instrument management, method validation, project management, etc.||Services page|
|PQE Group - North America||Rockville, MD, U.S.||Laboratory informatics, LIMS, laboratory instrument management, method validation, project management, etc.||Services page|
|RC Inspection Group||Rotterdam, Netherlands||Laboratory informatics, LIMS, data analysis, automation, etc.||Services page|
|RevereIT, LLC||Sterling, VA, U.S.||LIMS, system integration management, system validation, method development and validation,
data migration, vendor selection, etc.
|Sagit Solutions Ltd.||Wan Chai, Hong Kong||LIMS, implementation management, cloud management, vendor selection, etc.||Services page|
|Scimcon Limited||Newmarket, Suffolk, U.K.||Laboratory informatics, LIMS, ELN, CDS, SDMS, instrument management, project management||Services page|
|Semaphore Solutions, Inc.||Victoria, B.C., Canada||Laboratory informatics, LIMS, BaseSpace Clarity LIMS, workflow development, genomics||Services page|
|Sequence, Inc.||Morrisville, NC, U.S.||Laboratory informatics, LIMS, ELN, CDS, SDMS, data architecture analysis, data analytics||Services page|
|Shaw Informatics Ltd.||Horsham, West Sussex, U.K.||Laboratory informatics, LIMS, LES, ELN, process mapping, requirements analysis, project management,
vendor selection, deployment strategy, knowledge management solutions, training
|Silver Lining Informatics, LLC||Brooklyn, NY, U.S.||Laboratory informatics, LIMS, LES, ELN, Labware products, STARLIMS products, LabVantage products,
workflow development, reporting, project management, training
|Solution4Labs Sp. z o.o.||Białystok, Poland||Laboratory informatics, LIMS, ELN, custom development, Thermo Scientific products,
Agaram Technologies products, etc.
|SoftNLabs SpA||Croix, France||Laboratory informatics, LIMS, ELN, LES, SDMS, ERP, CRM, project management, software validation||Services page|
|Techsol Corporation||Princeton, NJ, U.S.||LIMS, QMS, MES, regulatory affairs, clinical development, software validation, analytics, etc.||Services page|
|The Thor Group||Redondo Beach, CA, U.S.||LIS, RIS, EHR optimization and implementation||Services page|
|Validation Systems, Inc.||Palo Alto, CA, U.S.||Laboratory informatics, microbiological and chemistry services, quality management systems,
computer system validation, etc.
|Verista||Fishers, IN, U.S.||Laboratory informatics, LIMS, ELN, CDS, laboratory compliance assessments, computer system validation,
project management, etc.
|wega Informatik AG||Basel, Switzerland||LIMS, data management systems design and implementation, clinical trial management systems,
and electronic data capture for life and chemical sciences
4.3 Other resources
4.3.1 ISO/IEC 17025 accreditation bodies
What follows is a set of examples of accreditation bodies handling ISO/IEC 17025 accreditation for laboratories around the world. For a more complete list of accreditation bodies, see the International Laboratory Accreditation Cooperation (ILAC) directory of approved bodies.
- Accredia, the Italian Accreditation Body (Italy)
- American Association for Laboratory Accreditation (A2LA) (U.S.)
- American Industrial Hygiene Association (AIHA) (U.S.)
- ANSI National Accreditation Board (ANAB) (U.S.)
- Bureau of Accreditation (BoA) (Vietnam)
- Canadian Association for Laboratory Accreditation (CALA) (Canada)
- Comité français d'accréditation (Cofrac) (France)
- Deutsche Akkreditierungsstelle (DAkkS) (Germany)
- Dutch Accreditation Council (RVA) (Netherlands)
- Egyptian Accreditation Council (EGAC) (Egypt)
- Institute for Accreditation of B&H (BATA) (Bosnia and Herzegovina)
- International Accreditation New Zealand (IANZ) (New Zealand)
- International Accreditation Service (IAS) (U.S.)
- Irish National Accreditation Board (INAB) (Ireland)
- Komite Akreditasi Nasional (KAN) (Indonesia)
- Korea Laboratory Accreditation Scheme (KOLAS) (South Korea)
- National Accreditation Board for Testing and Calibration Laboratories (NABL) (India)
- National Association of Testing Authorities (NATA) (Australia)
- National Research Council of Canada (NRC) (Canada)
- National Voluntary Laboratory Accreditation Program (NVLAP) (U.S.)
- Perry Johnson Laboratory Accreditation (PJLA) (U.S.)
- Spanish Association for Standardization and Certification (AENOR) (Spain)
- Standards Council of Canada (SCC) (Canada)
4.3.2 ISO/IEC 17025 reference and resource library
- Association of Public Health Laboratories (February 2018). "Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report" (PDF). https://www.aphl.org/aboutAPHL/publications/Documents/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf.
- Douglas, S.E. (21 February 2022). "FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors". LIMSwiki.org. https://www.limswiki.org/index.php/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors.
- Mehta, B. (2019) (PDF). Implementing ISO/IEC 17025:2017 (2nd ed.). ASQ Quality Press. ISBN 9780873899802. https://pasargadabzar.com/wp-content/uploads/2022/04/Implementing-ISOIEC-170252017-by-Bob-Mehta.pdf.
- National Association of Testing Authorities (April 2018). "General Accreditation Guidance: ISO/IEC 17025:2017 Gap analysis" (PDF). https://nata.com.au/files/2021/05/17025-2017-Gap-analysis.pdf.
- Perry Johnson Consulting, Inc (January 2022). "ISO/IEC 17025:2017 Testing and Calibration Laboratories: An Executive Overview" (PDF). https://www.pjcinc.com/Downloads/ISOIEC17025_exov.pdf.
- Portuguese Accreditation Institute (10 November 2019). "Guide for ISO/IEC 17025 Application" (PDF). http://www.ipac.pt/docs/publicdocs/requisitos/OGC001_GuiaAplicacao17025_v20181231_En_20191110.pdf.
- Vehring, S. (June 2020). "Tested & Accepted: Implementing ISO/IEC 17025:2017" (PDF). United Nations Industrial Development Organization. https://www.unido.org/sites/default/files/files/2020-06/Guide%20ISO%2017025-2017_online.pdf.
- Dror, Itiel E.; Pierce, Michal L. (1 May 2020). "ISO Standards Addressing Issues of Bias and Impartiality in Forensic Work" (in en). Journal of Forensic Sciences 65 (3): 800–808. doi:10.1111/1556-4029.14265. ISSN 0022-1198. https://onlinelibrary.wiley.com/doi/10.1111/1556-4029.14265.
- Krismastuti, Fransiska Sri Herwahyu; Habibie, Muhammad Haekal (1 December 2022). "Complying with the resource requirements of ISO/IEC 17025:2017 in Indonesian calibration and testing laboratories: current challenges and future directions" (in en). Accreditation and Quality Assurance 27 (6): 359–367. doi:10.1007/s00769-022-01523-w. ISSN 0949-1775. PMC PMC9579603. PMID 36275871. https://link.springer.com/10.1007/s00769-022-01523-w.
- Mandal, Goutam; Ansari, M. A.; Aswal, D. K. (1 September 2021). "Quality Management System at NPLI: Transition of ISO/IEC 17025 From 2005 to 2017 and Implementation of ISO 17034: 2016" (in en). MAPAN 36 (3): 657–668. doi:10.1007/s12647-021-00490-w. ISSN 0970-3950. PMC PMC8308083. https://link.springer.com/10.1007/s12647-021-00490-w.
- Miguel, Anna; Moreira, Renata; Oliveira, André (2021). "ISO/IEC 17025: History and Introduction of Concepts". Química Nova. doi:10.21577/0100-4042.20170726. https://www.limswiki.org/index.php/Journal:ISO/IEC_17025:_History_and_introduction_of_concepts.
- Monteiro Bastos da Silva, Juliana; Chaker, Jade; Martail, Audrey; Costa Moreira, Josino; David, Arthur; Le Bot, Barbara (26 January 2021). "Improving Exposure Assessment Using Non-Targeted and Suspect Screening: The ISO/IEC 17025: 2017 Quality Standard as a Guideline" (in en). Journal of Xenobiotics 11 (1): 1–15. doi:10.3390/jox11010001. ISSN 2039-4713. PMC PMC7838891. PMID 33530331. https://www.mdpi.com/2039-4713/11/1/1.
- Neves, Rodrigo S.; Da Silva, Daniel P.; Galhardo, Carlos E.C.; Ferreira, Erlon H.M.; Trommer, Rafael M.; Damasceno, Jailton C. (22 February 2017), Kounis, Leo D., ed., "Key Aspects for Implementing ISO/IEC 17025 Quality Management Systems at Materials Science Laboratories" (in en), Quality Control and Assurance - An Ancient Greek Term Re-Mastered (InTech), doi:10.5772/66100, ISBN 978-953-51-2921-9, http://www.intechopen.com/books/quality-control-and-assurance-an-ancient-greek-term-re-mastered/key-aspects-for-implementing-iso-iec-17025-quality-management-systems-at-materials-science-laborator
- Okezue, Mercy A.; Adeyeye, Mojisola C.; Byrn, Steve J.; Abiola, Victor O.; Clase, Kari L. (1 December 2020). "Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study" (in en). BMC Health Services Research 20 (1): 1065. doi:10.1186/s12913-020-05934-8. ISSN 1472-6963. PMC PMC7686690. PMID 33228675. https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-020-05934-8.
- Pillai, Segaran; Calvert, Jennifer; Fox, Elizabeth (3 November 2022). "Practical considerations for laboratories: Implementing a holistic quality management system". Frontiers in Bioengineering and Biotechnology 10: 1040103. doi:10.3389/fbioe.2022.1040103. ISSN 2296-4185. PMC PMC9670165. PMID 36406233. https://www.frontiersin.org/articles/10.3389/fbioe.2022.1040103/full.
Other useful documents:
LIMSpec is an ever-evolving set of software user requirements specifications for laboratory informatics systems, especially the laboratory information management system (LIMS). The specification has grown significantly from its humble origins over a decade ago. Earlier versions of LIMSpec focused on a mix of both regulatory requirements and clients' "wishlist" features for a given system. The wishlist items haven't necessarily been ignored by developers, but they do in fact have to be prioritized by the potential buyer as "nice to have" or "essential to system operation," or something in between. This latest version is different, focusing strictly on a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems.
At its core, LIMSpec is rooted in ASTM E1578-18 Standard Guide for Laboratory Informatics. With the latest version released in 2018, the standard includes an updated Laboratory Informatics Functional Requirements checklist, which "covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide." It goes on to state that the checklist "is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system," though it is certainly "not meant to be exhaustive."
LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources, including ISO/IEC 17025. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, the LIMSpec should also definitely be considered a continual work in progress, with more to be added as new pertinent regulations, standards, and guidance are discovered.
If you've never worked with a user requirements specification document, the concept remains relatively simple to grasp. Merriam-Webster defines a "specification" as "a detailed precise presentation of something or of a plan or proposal for something." Within this organized "plan or proposal" are requirements. A requirement typically comes in the form of a statement that begins with "the system/user/vendor shall/should ..." and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level), or it may be specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered.
An example of a functional software requirement could be "the user shall be able to query either all of the initial set of databases or select a subset from it." This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state "the system's query tool shall conform to the ABC 123-2014 standard." The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.
Section 3.1.2 of Chapter 3 took those specific LIMSpec requirements linked to ISO/IEC 17025 and presented them as a means to demonstrate the critical functionality a LIMS should have in order for a laboratory to more easily comply with the standard. However, there's more to LIMSpec than just those requirements. The requirements span multiple areas of laboratory workflow and practice, from the core functions of a lab to its ancillary operations, specialty functions, technology and performance touch points, and data and security touch points. As of December 2022, LIMSpec is based off more than 130 regulations, standards, guidance documents, and more, proving to be a robust starting point for labs seeking to use a requirements specification to acquire a LIMS.
The next chapter discusses the user requirements specification, using LIMSpec as an example. You'll learn how to shape such a specification to your laboratory's needs, how to issue the specification as a request for information (RFI), and how to get the most out of it when getting decision-related information from vendors.
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Citation information for this chapter
Chapter: 4. Resources for selecting and implementing informatics solutions
Title: LIMS Selection Guide for ISO/IEC 17025 Laboratories
Edition: First Edition
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: February 2023