Effectively Defining LIMS System Requirements - …

1 2 LIMS - LABORATORY INFORMATICS GUIDELABORATORY November 2006 Effectively Defining LIMSS ystem RequirementsLaunching a successful laboratory automation projectThe first step of any successfullaboratory automation projectbegins with clearly and suc-cinctly Defining the technicalrequirements of the data managementsystem along with the laboratory man-ager, end-user, It personnel and allother stakeholder needs many projects, this involves the cre-ation of a team that will work to createflow diagrams that capture the businessprocesses and rules of the organization,as well as interview and survey keystakeholders to gain a clear under-standing of the automation and datamanagement challenges. Once thisprocess is completed, project managersmust assign a priority to the variousrequirements that the new laboratoryautomaton solution must address.

2 Asecond and equally important step is toeffectively communicate those require-ments, project scope and cost range tothe vendor are several elements that mustbe clearly defined for any laboratoryinformation management System (LIMS) or laboratory automation proj-ect to be successful and to allow effectiveproject management; they include scope(S) which deals with the magnitude orsize of the project ( System Requirements )and is what we will focus on in thispresentation, realizing that we must alsoconsider, performance (P), cost (C) andtime (T) in relationship to refers to the quality of thework performed, Cost includes the laborcosts, software product costs, hardware(servers, firewall, PCs) and all relatedprojects costs and time refers to thelength of the project typically expressedin days, months or years to 1 depicts the relationshipbetween the key elements of any is clear to see that, if there is anincrease in scope, this will cause anincrease in the time and cost to comple-tion for the same level of the cost is the limiting project factor,then the scope may have to be scaledback or quality may be Defining LIMS systemrequirementsSince System size is a measure of themagnitude of all components of a sys-tem that are within the current scope,the System scope should be documentedin the project plan before the System sizeis estimated.

3 The scope statementdefines what the project will and will Christine Paszko, 1:The relationships between project scope,cost, time and performance (quality)LABORATORY INFORMATICS3 November 2006 include in enough detail to clearlycommunicate to all order to capture the laboratoryautomation and data managementrequirements in the implementation ofa LIMS, it is important to have a teamand a plan of attack that includes theprocess maps of the main functions thatthe laboratory is trying to LIMS projects, this involves thecreation of a cross-section of a multi-disciplinary laboratory managementteam that consists of laboratory man-agement (quality System engineers, proj-ect champion, and a regulatory expert),IT, and key end-users. This team willwork to create flow diagrams that cap-ture the business processes, as well asdefine the Requirements and rules of scope must be a complete defi-nition encompassing all types ofrequirements: The external business requirementsare generally the most obvious require-ments and those for which the defini-tion of scope is the easiest.

4 The System design may implyrequirements that are not specified. Forexample, the design of a client/serversystem may have the need for a fire wallbetween data moving in and out of theenvironment. Other components are often impliedbut not clearly defined, such as perform-ance, instrument interfaces, PDAs, oper-ations and implementation. These com-ponents should be included if they arewithin the scope of the System beingsized. If there is any question regardingwhether something is included, itshould be assumed to be within thescope of the sizing until the systemscope specifically excludes testing laboratories oftenshare many core Requirements for LIMS,which include sample tracking function-ality, data entry, electronic data entry,sample scheduling, stability, qualityanalysis/quality control (QA/QC), timetracking, chemical inventory, personneland equipment management and main-tenance.

5 In addition to these core fea-tures, laboratories often seek the abilityto integrate with enterprise applications,such as SAP, enterprise resource planning(ERP), or other similar managers may require specificreports or integration with other enter-prise solutions or accounting enhance productivity and dataaccuracy, laboratories often requireinstrument integration from their LIMSand data management tools that willmeet regulatory Requirements unique toa specific together key participantsthat represent a multi-disciplinary teamin a structured environment under thedirection of a trained facilitator cansolidify the problem definition and leadto the production of a problem specifi-cation which will serve as the founda-tion on which to build the requirementsdocument or request for a multifunctional team is assem-bled.

6 They can analyze their businessprocesses identify bottlenecks and com-municate their wants or desires from thesystem and the business advantage thatthe proposed solution is to start with, the team shouldapproach end-user Requirements gather-ing by following the traditional systemdevelopment life cycle route with inter-views, extensive research, process analy-sis and other tasks appropriate to astructured analysis. This can be doneinternally, or an outside consultant oreven the LIMS vendor partner can con-duct this assessment. There are advan-tages to having an outside firm performthe needs assessment as they can beobjective and have extensive experienceand can offer suggestions and sharesolutions that were successful in similarprojects. One advantage of utilizing out-side vendor partners is that you willhave the opportunity to evaluate theirexpertise and they will have the advan-tage of seeing some of the challengeslaboratories are facing firsthand prior tomaking any recommendations for orimplementing any new laboratoryautomation the decision is made to completethe needs assessment internally, beloware some suggested steps to completingthe task.

7 It does not require a significanttechnical knowledge to develop func-tional Requirements . It is also importantto note that not all advantages are limit-ed to a reduction in operating costs,some deal with improvements in qualityand improved client satisfaction. A keytask is to assign a group to identify andobtain any documents that describe thecustomer needs; this could consist ofFIGURE 2:An example of Requirements from a request for Test Processing and log test requests received in a user defined message to create test-request records in the LIMS directly from elec-tronic test request records in a variety of formats, (this refers to theability to edit an electronic test request record). Test records shallalso include information on the contents of sample packages ( , aphysical package where a package may contain multiple samples) to create a list of submitters with submitter contact informa-tion (including the possibility of multiple contacts for each submit-ter).

8 Authorized users will have the ability to make a submitter orcontact active or inactive in the LIMS (inactive submitters orsubmitter contacts are those who will no longer be submitting sam-ples to the lab) to review electronic test request records and return acknowl-edgement messages to submitter verifying receipt and processingof the transmission with electronic carbon copy. 4 LIMS - LABORATORY INFORMATICS GUIDELABORATORY November 2006any formal studies that were conducted,a statement of work (SOW) or a requestfor proposal (RFP). These documentswill provide good overviews but, to getthe specifics, it is important to conductinterviews. Before interviews can begin,key people must be identified and across section of members from differentdepartments that are represented in themultidisciplinary team should be inter-viewed.

9 It is important to identify theright people to interview; one dissatis-fied person can do a significant amountof damage and can sabotage the are some suggested interviewingtips that include the following: Let the interviewee know that youare there to help solve a problem andthat their input is critical to finding asolution Ensure the interviewee that automa-tion will not replace them, it will onlyeliminate mundane tasks so that theycan be available to work on more chal-lenging tasks Share the information that has beencollected from interviews with the restof the team. This information sharingcreates trust and partnerships that willlead to obtaining more information Following the interview, summarizethe interviewee s answers and read themback to them for accuracy Be prepared for the interview andcreate a script that asks the same ques-tions of a number of interviewees.

10 Thiscan lead to a statistical sampling anduseful data Don t assume anything. If an inter-viewee says that this technology will savetheir departments a hundred hours, askothers in the department to confirm are two kinds of performancerequirements, which together definespecifications ( System Requirements );these include the functional and technicalrequirements. According to Wikipedia; Arequirement is defined as a singular doc-umented need of what a particular prod-uct or service should be or do. Functional Requirements Thesedescribe what the deliverable supposedto example the LIMS must automat-ically e-mail status reports and post acopy to the LIMS intranet site. Technical Requirements Thesedescribe the features of the example, the reports must be inread-only PDF requirementsOnce this process is completed andthe team has summarized all of thefunctional and technical Requirements ,project managers must assign a priorityto the various Requirements that thenew laboratory automaton solutionmust address.