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WHITE PAPERLIMS FOR TESTING LABORATORIES –AN OVERVIEW OF FEATURESANDCOMPLIANCE FOR TESTING LABORATORIES427 N Tatnall St #42818 Wilmington DE 19801-2230 USAwww.cloudlims.com support@cloudlims.com 1-302-789-0447
LIMS FOR TESTING LABORATORIES – AN OVERVIEW OF FEATURES AND COMPLIANCE FOR TESTING LABORATORIESA laboratory that performs any type of test can becategorized as a testing laboratory. There aredifferent types of testing laboratories such as foodand beverage, environmental, cannabis, clinical,petrochemical, etc. Each testing laboratory needsto follow certain standard guidelines andcompliance in order to receive recognition fromregulatory bodies. The recognized InternationalStandard for testing laboratories is ISO/IEC17025:2005. It underlines the general competencerequirements to carry out test and calibrationacross the globe. Additionally, it includes testingand calibration performed using developed methods. The standards areto be maintained by all laboratories performingtest and/or calibration regardless of the sector towhich it belongs i.e. private, government,semi-government, etc. Test results obtained byISO/IEC 17025 compliant laboratories are reliedupon by regulatory bodies and their customers. ALaboratory Information Management System(LIMS) can help testing laboratories to seamlesslymeet the compliance requirements and presentthe testing data to third-party regulatoryauthorities during auditing. This white paperpresents a general overview of the features andcompliance requirements of testing laboratoriesand explains how a LIMS can help theselaboratories meet them.qualitative and quantitative.TYPE OF TESTSREQUIREMENTS OF ISO/IEC 17025At the highest level, there are two types of teststhat testing laboratories usually perform:Any testing laboratory interested to meetinternational testing standards and receiveQualitative Test: A qualitative test is used todetermine the presence of an analyte in a samplebased on its physical, chemical and biologicalproperties. The response of a qualitative methodis either the presence or absence of the analytebeing tested in a sample. It does not determine theabsolute/relative quantity of the analyte present inthe sample.Quantitative Test: A quantitative test provides anaccurate estimation of the quantity of one or moreanalytes present in a sample.To determine the accuracy of a quantitative testresult, the test is replicated. The tests can berepeated as many times as required to ascertainthe accuracy of the test result. There are twodifferent methods to replicate a test.1) The test can be performed either by the sametechnician twice.2) Alternatively, two different technicians canperform the same test and the observed values ofboth tests can be compared to determine theaccuracy of the test result.Sometimes, the average of all observed values iscalculated to determine the quantity of an analytepresent in a sample.1www.cloudlims.com support@cloudlims.com 1-302-789-0447
LIMS FOR TESTING LABORATORIES – AN OVERVIEW OF FEATURES AND COMPLIANCE FOR TESTING LABORATORIESISO/IEC 17025 certification has to meet certainrequirements. Some of them are outlined below:1) Technical RequirementsPerforming any TestofPersonnelTechnical competence of technicians performinglaboratory tests is an important factor whichgoverns the accuracy of test results. The testinglaboratory should have an appropriate procedurefor recruitment of efficient technicians. Thetechnicians should have relevant practicalexperience and should be proficient enough toconduct specific tests without supervision. Postrecruitment, the laboratory should take care of thetraining of the recruited technicians. This is toensure that they have the required technicalacumen for performing the tests assigned to them.The training program should include details of allmethods or parts of methods and techniques thata technician is required to perform for successfullyaccomplishing the test. All relevant internal orexternal training details should be an/analyst should also demonstrate theircompetency to conduct the test. Additionally, thelaboratory supervisor/PI should continuouslymonitor the competency of all techniciansperforming tests using appropriate means (forexample, visual observation).2) Laboratory Work Space Organization andEnvironmental ConditionsIn order to minimize any possible chances ofcross-contamination, it is imperative to organizeall laboratory activities associated with any test. Alaboratory workspace should be organized so thatvarious activities such as sample preparation,extraction and analysis are spatially segregated.Alternatively, if a laboratory has a spaceconstraint, the different activities should beperformed at different time points.Proper ventilation of a testing laboratory is crucialtoavoidanycross-contamination. Thetemperature and humidity should be monitoredclosely round the clock.3) EquipmentA testing laboratory should be fully equipped withthe instruments required for the accurateperformance of all tests. All testing equipmentrequired for sampling, processing, and analysis ofexperimental test data should be available instandard condition in the laboratory. Additionally,the instruments requiring calibration should becalibrated as required to ensure accuracy of testresults. A LIMS can help a laboratory managersetup calibration date reminders and maintenanceschedules on time for such instruments so that theaccuracy of test results is not compromised.4) Choice of Test MethodsThere is no restriction as far as the selection of atest method is concerned. The test method(s) canbe determined based on the requirements of theclient. All information pertaining to the new test2www.cloudlims.com support@cloudlims.com 1-302-789-0447
LIMS FOR TESTING LABORATORIES – AN OVERVIEW OF FEATURES AND COMPLIANCE FOR TESTING LABORATORIESmethod should be disseminated to the client toensure the range and accuracy of values obtainedare in accordance with the client's needs. Alaboratory can use a test method that is not takenfrom validated sources. However, any new testmethod needs to be properly validated beforeimplementation. Besides, there should be detaileddocumentation of the new method for referenceand auditing purposes. Whenever feasible, thetesting methods should comply with the essentialelements of regulatory standards.performed to determine the validation parameters,signature of authorized personnel, etc. Once amethod is validated, it can be used by thelaboratory. The test results generated using thismethod should be duly signed along with a dateand time stamp by an approving authority. A LIMScan help a laboratory manager/or authorizedperson to electronically record the results alongwith the date and time stamp and digitally sign it.These electronic records are referred to by theregulatory bodies during the audit process.5) Validation of the Test MethodPeriodical inspection of the implemented validatedmethod is also required in order to confirmaccuracy of the ongoing method. A LIMS can helpin documenting the required frequency ofinspection of validated methods and can timelyalert the laboratory manager.Validation of a test method is crucial for anytesting laboratory because it helps to ascertain theappropriateness of the test method for theintended purpose. For example, a methoddeveloped for determining the presence of acontaminant/microorganism in a food sampleshould be first validated to ensure that it canaccurately identify the contaminan/microorganism.The method used for testing should meet the setstandards for validation such as accuracy,specificity, calibration, range/limit of detection,ability to obtain the same, or almost the same testresults on identical test material, under the sameconditions within a short interval of time (i.e.,repeatability) and the ability to obtain the same ornearly the same test results under differentconditions (i.e., reproducibility). A methodvalidation document is expected to include adetailed description of the test method used,preparation of calibration standard, potentialinterferences, a brief outline of the tests6) Proficiency TestingThis type of test helps monitor continuousperformance of a laboratory for specific tests. Inorder to ensure that the testing laboratorycontinues to be ISO/IEC 17025 compliant, theyare regularly monitored through proficiencytesting. Participation of competent laboratories inproficiency testing and inter-laboratory test resultcomparison may be required periodically todemonstrate their technical competence. If alaboratory shows poor performance duringproficiency testing, it needs to determine thefactors responsible for poor performance and takethe appropriate corrective measures.3www.cloudlims.com support@cloudlims.com 1-302-789-0447
LIMS FOR TESTING LABORATORIES – AN OVERVIEW OF FEATURES AND COMPLIANCE FOR TESTING LABORATORIESGOOD LABORATORY PRACTICE (GLP)GLP compliance is a set of principles designed toregulate the non-clinical safety testing of analytespresent in pesticides, cosmetics, veterinary drugs,food items, industrial chemicals, etc. The primaryobjective of GLP principles is to promotegeneration of high quality test data that isvalidated. When data is submitted by a GLPcompliant laboratory, it assures regulatoryauthorities that it corresponds to the actual resultsobtained during a study/test, deeming it asreliable. GLP principles are not intended to definescientific standards, rather it defines the qualitystandards for conducting a test or study, datacollection, and reporting of results.GLP Principles Include:1) SOP (Standard Operating Procedure)This outlines step-by step instructions to helplaboratory personnel carry out routine testingoperations. GLP does not exactly specify all thenecessary details to be included whiledocumenting SOPs. However, it ascertains that alllaboratory personnel follow the same proceduresas documented in the SOP. A LIMS can help inelectronically documenting SOPs, and providequick access to all authorized users.2) Proper Labeling of ReagentsProper labeling of reagents is essential for anytesting laboratory because it enables laboratorypersonnel to quickly identify details of a reagentsuch as its concentration, expiration date, storagerequirements, etc. A LIMS can be integrated withlabel printers to print appropriate labels, which canbe easily pasted on the reagent container. Thisreduces the chances of manual errors.Additionally, a LIMS can alert laboratorymanager(s) to replenish stock reagents beforethey deplete/expire by setting an alarm level andan expiration date. This prevents any delay inperforming tests due to the unavailability ofrequired reagents.3) Reporting of Experimental Data and Resultsand its Secure ArchivalGLP requires experimental data, study plans andfinal reports to be systematically and securelysaved for record keeping, reporting and retrievalwhenever required. A LIMS can prove to be apivotal tool for securely archiving this information.Electronically saving the data in a LIMS alsoeliminates the legibility issues that is introducedwhile recording manually.Laboratories performing clinical tests usingbiospecimens should follow Good ClinicalLaboratory Practice (GCLP). A clinical testinglaboratory must have documented procedures forcollection of specimens, transportation, andreceiving of specimens. This is imperativebecause the accuracy of test results will dependon the integrity of the sample submitted to thelaboratory for testing.4www.cloudlims.com support@cloudlims.com 1-302-789-0447
LIMS FOR TESTING LABORATORIES – AN OVERVIEW OF FEATURES AND COMPLIANCE FOR TESTING Sample Testingvia ingSample Disposalor Storagefor Further UseSampleAccessioningSampleCollectionA schematic representation of a testing laboratory workflowThe sample must have the following information:collection site, collector's identity, sample type,collection date and other relevant information. ALIMS empowers laboratories to securely maintainthis information. Any missing information shouldbe properly investigated by the laboratorypersonnel before storing the sample. A completeaudit trail, from the time a sample is collected untilthe time it is disposed off, must be maintained.HOW A LIMS CAN AUTOMATE TESTINGLABORATORY WORKFLOWS?1) Any testing laboratory usually generates a lot ofdata. To seamlessly manage such big data, a LIMSplays a key role. It helps in managing samples,tests, experimental data, control limits, and testresults. Besides, any changes made to the testresults is recorded in an audit trail. A LIMS helps inautomatic accessioning of samples. Each sampleis assigned a unique sample ID and subsequentlyassociated with specific test(s) along with the ID ofthe technician performing the test. A LIMS canalso automatically generate unique barcodes foreach sample tested, thereby automating thesample tracking process.2) A chain of custody (COC) is required in manylaboratories that handle environmental, clinical,and forensic testing, as well as other laboratoriesthat want to assure reliability of reported results. Itis required in laboratories that handle samples5www.cloudlims.com support@cloudlims.com 1-302-789-0447
LIMS FOR TESTING LABORATORIES – AN OVERVIEW OF FEATURES AND COMPLIANCE FOR TESTING LABORATORIESbound by legal or regulatory directives, includingthose enforced by United States governmentagencies such as the Department ofTransportation (US DOT), the EnvironmentalProtection Agency (US EPA), and the Food andDrug Administration (US FDA). To meet thoselegal and regulatory requirements, manylaboratories are required to maintain a detailedchain of custody for all samples that move throughtheir facilities. A LIMS facilitates maintainingChain of Custody (COC) for all tests performed bya laboratory.3) In testing laboratories, manual entry ofanalytical instrument data to a LIMS drasticallyhinders laboratory efficiency since it is error-proneand time consuming. A LIMS can be directlyintegrated with analytical instruments through anApplication Programming Interface (API) tofacilitate seamless uni-directional or bidirectionaldata transfer. This minimizes the chances ofmanual errors and reduces sample turnaroundtime, thereby escalating laboratory efficiency.4) Flagging of test results which fall outside thenormal reference range is crucial to bring it to theimmediate attention of the technician performingthe test or data reviewers. Abnormal test resultscan be attributed to a number of factors such aserror in sample processing, error in performing thetest, sample contamination, etc. It is also possiblethat the analyte being tested actually falls outsidethe normal reference range. A LIMS automaticallyflags test results if it falls outside the referencerange. This helps the technician/ laboratorymanager to determine if a test needs to berepeated in order to confirm accuracy of the testresult. If it is a quality assurance test, this wouldresult in the batch being rejected for failing tomeet the quality criteria.5) Preserving data integrity is of paramountimportance. In order to get approval fromregulatory authorities, it is important to assurethem that the data submitted is the actual dataobtained during a test, and hence data integrityhas not been compromised. A LIMS helps inpreserving integrity of the test data and preventsunauthorized data obscuring or modification. Anychanges made are authenticated by an authorizeduser through digital signature and are auditrecorded. Thus, a LIMS enables testinglaboratories to get approval from regulatoryauthorities seamlessly.6) Manual generation of test report or certificate ofanalysis, and its delivery to the client or theconcerned person is a major cause of inefficiency.By automating test report generation and deliveryof the reports, a testing laboratory can enhance itsefficiency and can enable laboratory researchersto focus on their actual work. A LIMS facilitatesautomated test report generation in an attractiveformat for presentation to the client or regulatoryauthorities. Besides, it also facilitates automatedemailing of test results to the client, therebyreducing sample turnaround time.6www.cloudlims.com support@cloudlims.com 1-302-789-0447
LIMS FOR TESTING LABORATORIES – AN OVERVIEW OF FEATURES AND COMPLIANCE FOR TESTING LABORATORIESCLOUD-BASED LIMSLABORATORIESFORTESTINGA cloud-based LIMS is a cost effective LIMSsolution with innumerable service advantages. Incase of cloud-based LIMS, the actual LIMSsoftware resides on a highly secure remote serverand all authorized users can access it using theirunique login credentials. Since the data is on thecloud, users can access it anytime, anywhere,using an internet-ready device. Cloud technologyenables researchers and laboratories to sharetheir data and results in real time with externalresearchers and their clients, thereby minimizingthe testing turnaround time. Additionally, itminimizes the chances of data loss due to naturalcalamities since the data is saved on mirrorservers located in disparate geographicallocations. A cloud-based LIMS is highly scalablewhich enables laboratories to seamlessly copewith the ever changing laboratory datamanagement needs. Software as a Service (SaaS)is the preferred delivery model of a cloud-basedLIMS. SaaS leverages the power of Pay As You Go(PAYG) payment model to reduce expenses.Laboratory users can simply subscribe to use thesoftware and scale as the laboratory requirementsincrease. Hence, a cloud-based LIMS requiresvirtually a zero budgetary outlay, unlikeon-premise LIMS, and is the preferred choice oftesting laboratories for managing their data,reporting test results and for automatinglaboratory workflows.CONCLUSIONTesting laboratories are under constant pressureto reduce cost, enhance efficiency and constantlyimprovise the quality of search results. Theselaboratories need to effectively manage the entirelife-cycle of each test sample, which includessample accessioning, recording tests performedon the samples, managing experimental data andtest results, besides permanent disposal ofsamples (if required). These laboratories are alsosubjected to compliance such as ISO/IEC 17025,GLP, and are required to follow them in order toreceive international recognition from regulatoryauthorities. Managing laboratory data and meetingthe regulatory requirements can be challenging,time consuming, and tedious. A cost-effectivecloud-based LIMS seamlessly aids testinglaboratories in managing big data, automatinglaboratory workflows and in meeting regulatorycompliance, thereby saving time, cost andresources.7427 N Tatnall St #42818 Wilmington DE 19801-2230 USwww.cloudlims.com support@cloudlims.com 1-302-789-0447
their facilities. A LIMS facilitates maintaining Chain of Custody (COC) for all tests performed by a laboratory. 3) In testing laboratories, manual entry of analytical instrument data to a LIMS drastically hinders laboratory efficiency since it is error-prone and time consuming. A LIMS can be directly integrated with analytical instruments .
