Traceability management of systems of systems: A systematic review in the assisted reproduction domain

T aceabili y Managemen o Sys ems o Sys ems: A Sys ema ic Re iew in he Assis ed Rep oduc ion Domain Le icia Mo ales T ujillo1, Julián Albe o Ga cía1, Da id Lizcano2 and Manuel Mejías1 1Uni e si y o Se ille, Escuela T´ecnica Supe io de Ingenie ´ıa In o m´a ica, Web Enginee ing and Ea ly Tes ing (IWT2) g oup A da. Reina Me cedes s/n. 41012 Se illa, Spain 2Uni e sidad a Dis ancia de Mad id (UDIMA), Mad id, Spain E-mail: [email p o ec ed]g; [email p o ec ed]; [email p o ec ed]; [email p o ec ed] Abs ac O e las decade, Assis ed Rep oduc i e T ea men (ART) has become a e y used heal h se ice by mo e and mo e people a ound he wo ld because o p oblems such as he delay in he ma e ni y age, single- pa en couples, e c. In his con ex , heal h agencies ha e pe o med inno a ions o imp o e heal hca e p ocesses o ARTs, o op imize he pe o mance o heal h p o essionals who wo k in e iliza ion labo a o- ies and o imp o e Biological Sample Managemen (BSM) and sample aceabili y in ART. Howe e , he e a e impo an handicaps in ART p ocesses om he poin o iew o quali y, sa e y and managemen . On he one hand, hese p ocesses a e mainly based on manual execu ion asks and manual con ol asks.This excess o manual asks could lead o Jou nal o Web Enginee ing, Vol. 18 4-6, 409–446. doi: 10.13052/jwe1540-9589.18466 c 410 L. M. T ujillo e al. a al aceabili y and sa e y e o s du ing BSM. On he o he hand,ART p ocesses equi e eal, in e ope able and aceable communica ions be ween di e en so wa e sys ems ha ha e o collabo a e oge he (heal h in o ma ion sys ems, biological sample managemen sys ems, pa ien managemen sys ems, e c.), bu , a p esen , i is possible o iden i y some limi a ions in his domain, ha is, he domain o sys ems o sys ems (SoS). This pape aims o conduc an exhaus i e s udy was ca ied ou bo h in he esea ch communi y and in he comme cial ield o iden i y and analyze SoS solu ions and heo e ical p oposals o BSM in ART p ocesses. We ha e applied he Sys ema ic Li e a u e Re iew (SLR) me hodology o ca y ou ou s udy and we conclude i is a e y young esea ch line ha shows a g owing end and ha in he ac uali y he e a e e y ew echnologies ha deal wi h he p oblem o he BSM in ART.A e analyzing he esul s, his pape p esen s as u u e wo k an ini ial Model-D i en concep ual solu ion o imp o e BSM in ART. Keywo ds: Sys ema ic Li e a u e Re iew, Sys ems o Sys ems, Bio- logical Sample Managemen , Assis ed Rep oduc i e T ea men . 1 In oduc ion I is a wo ldwide accep ed knowledge ha in he las yea s, p ocess managemen has become a sui able s a egy o inc ease excellence and p oduc i i y in any kind o o ganiza ion and business domain [1]. This s a egy ies o assess p ocesses and imp o e hei e ec i eness and e iciency o educe cos s and imp o e quali y, p oduc i i y, aceabili y o a i ac s wi hin o ganiza ional p ocesses and compe i i eness. In his sense, his pape is con ex ualized wi hin he domain known as SoS whe e mul iple, dispe sed and independen sys ems a e in con ex as pa o a la ge and mo e complex sys em. Mo e speci ically, i is con ex ualized wi h he Assis ed Rep oduc ion T ea men (ART) p ocesses [2] and how so wa e enginee ing p o ides solu ions and echniques o imp o e he managemen o hese p ocesses and he managemen and aceabili y o hei a e ac s (i.e. biological samples). O e las decade, ART has become a e y used heal h se ice by mo e and mo e sen imen al couple a ound he wo ld because o T aceabili y Managemen o Sys ems o Sys ems 411 p oblems such as e ili y limi ing pa hologies, delay in he ma e - ni y age, single-pa en couples, homosexual couples and women who wish o ace ma e ni y indi idually [3], among o he s. In ac , some epidemiological s udies conclude ha In e ili y pa hologies a ec 15% o he popula ion o ep oduc i e age in Wes e n coun ies (i.e., one in six couples) and his pe cen age is g adually inc easing e e y yea [4]. Howe e , hese da a can be ex apola ed o o he coun ies. Fo example, Spain is Eu ope’s leade in ART. In his Eu opean coun y, 127,809 ART p ocesses and 38,903 a i icial insemina ions we e ca ied ou in 2015 acco ding o he la es da a om he Minis y o Heal h, wha implied 36,318 bi hs in Spain using hese echniques ( hese bi hs ep esen 8% o he o al bi hs in Spain ha yea ) [5]. Despi e he upwa d end in he applica ion o ART p ocesses a ound he wo ld, he e a e many aspec s ha should be imp o ed du ing he execu ion o hese p ocesses [6]. One o he mos c i ical aspec s is o es ablish and de ine quali y and con ol mechanisms [7] in Biological Sample Managemen (BSM) and aceabili y o biological samples in ART when hese biological samples (o ules, spe m and emb yos) a e manipula ed by emb yologis s in e iliza ion labo a o- ies. The de ini ion o con ol mechanisms o gua an ee aceabili y and imp o e BSM is a e y impo an and c i ical aspec in his domain because any iden i ica ion e o o biological samples could cause heal h p oblems o he pa ien and, e en, legal p oblems [8–10]. An iden i ica ion e o occu s when a pa ien is mis akenly pai ed wi h a diagnos ic es , biological samples o ART p ocess, and i could be usually caused by en i onmen al and echnical aspec s. Rega ding en i onmen al aspec s, we mainly e e s o sociologi- cal aspec s and en i onmen al s ess o emb yologis and labo a o y p o essionals [11]. The p esence o in ense en i onmen al causes clea physiological eac ions on heal h p o essionals who wo k in e iliza- ion labo a o ies, such as pe cep ion o discom o , wo k o e load, discom o and anxie y symp oms, de ia ion o a en ion and lack o concen a ion, and beha io al de ici s, among o he s. These ac o s and he sys ema iza ion o he wo k ca ied ou by emb yologis s a e he main causes o e o s in BSM and aceabili y o biological samples in ART. In his con ex , double-manual checking p o ocol [12] 412 L. M. T ujillo e al. was p oposed as mechanism o minimize hese e o s. Howe e , his p o ocol does no sol e he p oblem because i duplica es he numbe o manual asks pe o med, as well as he ex a documen a ion o documen esul s o con ol asks. Rega ding echnical aspec s, we e e o how he in o ma ion gen- e a ed du ing he li ecycle o he biological sample is managed om he ime he sample is ob ained un il i eaches i s des ina ion (i.e., eezing, insemina ion, e c., in he case o ART p ocesses). The managemen o his in o ma ion has been his o ically pe o med by emb yologis s on pape , sp eadshee s o small da abases [13]. Howe e , hese da a o ma s di icul da a managemen and aceabili y o in o ma ion. These si ua ions also p one o gene a e duplica e in o ma ion which o ces emb yologis s o pe o m con iguous checks o co obo a e he co ec use o samples in each execu ion o ART p ocesses. A p esen , hese si ua ions and aspec s a e especially c i ical oday because i is usually o use di e en so wa e sys ems du ing clini- cal p ac ice in ART. These p ocesses equi e eal, in e ope able and aceable communica ions be ween di e en so wa e sys ems (domain o sys ems o sys ems, SoS) ha ha e o collabo a e oge he (heal h in o ma ion sys ems, biological sample managemen sys ems, pa ien managemen sys ems, con ol sys ems o physical labo a o y de ices such as biological sample eeze s, e c.), bu , a p esen , i is possible o iden i y some limi a ions. In his con ex , his pape p esen s an exhaus i e s udy o iden i y and analyze SoS solu ions and heo e ical p oposals o BSM in ART p ocesses. Howe e , i is impo an o men ion ha his s udy is jus one piece o a mo e ambi ious esea ch s a egy. Once he s a e-o - he-a o his subjec is known, ou objec i e is o p opose a Model-D i en amewo k o acili a e he design and de elopmen o in o ma ion sys ems o ien ed o he managemen o biological samples and he aceabili y o hese samples h oughou hei li ecycle. Fi s ly, ou in en ion is o guide his u u e amewo k owa ds ART p ocesses in a non-in asi e way. Howe e , we plan also o de ine his amewo k in a gene ic way o p o ide suppo o any ype o biological sample om di e en a eas (ag icul u e, ood, heal h, e c.). Finally, we wan o men ion ha we ha e ca ied ou an ini ial sea ch o ound ela ed wo ks T aceabili y Managemen o Sys ems o Sys ems 413 in o de o know o he sys ema ic e iew on his opic (i.e., BSM in ART p ocess). Howe e , we ha e no ob ain any esul s wha highligh he impo ance o ou s udy. This pape is s uc u ed as ollows. Func ional con ex o ou esea ch a e b ie ly desc ibed in Sec ion 2. La e , he me hod used o he s udy and i s planning a e p esen ed in Sec ions 3 and 4, espec i ely. Once decided how he s udy is going o be pe o med, he e iew p o ocol whose esul s a e p esen ed in Sec ion 5 was conduc ed. La e , Sec ion 6 o e discussions on hese esul s. A e analyzing he scien i ic and echnical li e a u e ela ed o he domain unde s udy, Sec ion 7 desc ibes ou u u e wo k and p esen s an ini ial concep ual scheme o ou p oposal di ec ed by models o imp o e BSM and aceabili y o samples in ART p ocesses. Finally, Sec ion 8 s a es a se o conclusions. 2 Backg ound This sec ion desc ibes b ie ly he backg ound and unc ional con ex o ou esea ch. These aspec s a e ocused in he con ex o ART p ocesses which a e amed wi hin he SoS domain.In his con ex , as men ioned abo e, one o he mos commonly used mechanism o a oid possible e o s in BSM and aceabili y o biological samples in ART is double- manual checking (DMC) p o ocol [12]. This p o ocol is based on he con ol o manual asks pe o med by main emb yologis s (known as «ope a o ») h ough ano he emb yol- ogis (known as «wi ness») who jus e i ies asks o he o me . The main objec i e o his p o ocol is o de ec any e o commi ed by he ope a o as soon as possible so ha i can be sol ed in ime. The wi ness aims o iden i y hese e o s. Howe e , some s udies sugges ha DMC p o ocol is no as sa e and e ec i e as i seems o be [14]. The main eason is in he pe o mance o epe i i e asks by bo h p o essionals («ope a o » and «wi ness»). These epe i i e and manual asks could ge o educe he e ec i eness o his p o ocol because he a en ion le els o bo h p o essionals dec ease when he same ac ion is epea ed by he same pe son. The e o e, his p o ocol does no sol e he p oblem in BSM and aceabili y o biological samples because i duplica es he 414 L. M. T ujillo e al. numbe o manual asks pe o med, as well as he ex a documen a ion o documen esul s o con ol asks. Howe e , he e a e some al e na i es o DMC p o ocol ha a e based on physical de ices and so wa e con ol sys ems. On he one hand, he e a e sys ems based on ba codes ha a e used in conjunc ion wi h DMC p o ocol. These sys ems iden i y each c yop ese a ion de ices (pipe e, Pe i dish, i i ica ion de ices, e c.) wi h a ba code and he «ope a o » has o use a ba code eade when s/he is handling a c yop ese a ion de ices. This me hodology allows egis e ing in a so wa e sys em whe e each biological sample is and when i is manipula ed. In his con ex , his kind o sys ems i sel could ea ly ale when a biological sample is going o be inco ec ly used in a di e en ins ance o he ART p ocess. Howe e , some handicap can be iden i ied. Fi s ly, his me hod is a eac i e me hod since i wo ks i he ba code eade is used. Secondly, ega ding ba codes, he Eu opean Commission has s anda dized his iden i ie o inc ease he con idence o his con ol echnique [15]. This Eu opean di ec i e es ablishes echnical equi emen s o he coding o human cells and issues. Howe e , he e is ano he ac o ha hinde s he implemen a ion in eal en i onmen s in ART domain. This code is based on s ings o 40 cha ac e s. This ex is oo la ge o be p in ed on c yop ese a ion de ices. On he o he hand, he e a e also sys ems based on adio- equency iden i ica ion (RFID) echnology. In his case, i is necessa y o place an RFID adhesi e ag on each c yop ese a ion de ice. Each label encodes a unique and unambiguous pa ien e e ence. This ype o iden i ica ion and aceabili y sys em allows egis e ing he loca ion o each label h oughou he execu ion o an ART p ocess as well as who is manipula ing he de ice ha con e s his RFID ag. The ad an age o his sys em o e ba code sys ems is he p o-ac i i y o RFID sys ems. The «ope a o » does no need o use any ag eade since hese ags a e au oma ically ead by senso s placed in di e en loca ions in he labo a o y. Al hough some companies ha e p oposed echnical solu ions based on RFID echnology [16], hese solu ions a e expensi e, no e y lexible and a e aimed a labo a o ies wi h speci ic a chi ec u e and spa ial dis ibu ion. In addi ion, i is T aceabili y Managemen o Sys ems o Sys ems 415 necessa y o use all he c yop ese a ion de ices p o ided by hese companies. Once backg ound is p esen ed, i is also in e es ing o know how ART clinics and ART uni s usually wo k. This unc ional in o ma ion is impo an o adequa ely ocus on he sys ema ic e iew desc ibed in ollowing sec ions o his pape . In his sense, we ha e used he p ocedu e implan ed in Inebi [17] as unc ional case which desc ibes he ac ions ca ied ou wi hin he ART p ocesses. We ha e used ac i i y diag ams o UML (Uni ied Modeling Language) o ep esen hese p ocesses. Thanks o hese ac i i y diag ams, i was possible o know he ac o s and he a i ac s, de ices o in o ma ion suppo s in ol ed a each momen , as well as he place whe e each ac ion is ca ied ou . The ollowing is an example o he ac i i y diag am (Figu e 1) co esponding o he p ocess o ex ac ion o oocy es culmina ing in he conse a ion o he oocy es ob ained. As can be seen in he illus a ion abo e, he ac o s in ol ed in his p ocess a e, on he one hand, gynecologis s, nu ses and nu sing assis an s in cha ge o ex ac ing he oocy es om he pa ien , wi h he aid o an oocy e punc u e needle, in he su ge y and, on he o he hand, in he labo a o y in he da k, a e he emb yologis s and labo a o y echnician who a e in cha ge o p epa ing he oocy es ex ac ed om cul u e pla es o hei subsequen conse a ion in an incuba o . All he in o ma ion abou he p ocess is collec ed in he ea men shee , which a e in pape o ma . In addi ion o he p ocess o oocy e ex ac ion and p ese a ion, 3 mo e p ocesses we e s udied. The p ocess o seminal p epa a ion, he p ocess o o ules e iliza ion and subsequen ans e and, inally, he p ocess o c yop ese a ion o samples. The gene al ision ob ained a e his case s udy is ha despi e being a clinic wi h all he ad ances in labo a o y echnology, whe e he p egnancy a e is highe han he na ional a e age, i is necessa y o imp o e he aceabili y con ol sys em. Today hey con inue o make use o he DMC p o ocol. Al hough he e idence sugges s ha i may no be as sa e and e ec i e because he e ec s o mechaniza ion may dec ease le els o ca e. In addi ion, i in ol es he duplica ion o esou ces in an al eady expensi e p ocess. 416 L. M. T ujillo e al. Figu e 1 Ex ac ion o oocy es. In addi ion, a p esen all he in o ma ion ob ained om labo a o y p ocesses is collec ed in pape o ma and independen o he clinic’s pa ien managemen so wa e. This means, among o he hings, a double o iple wo k, because many o hese in o ma ion suppo s mus be upda ed pe iodically which leads o he ealiza ion o a new one om ime o ime. 3 Re iew Me hod This pape desc ibes he applica ion o one o he mos widely accep ed me hods in he a ea o so wa e enginee ing o pe o m Sys ema ic Li e a u e Re iew (SLR) as o he esea che s ha e done in pape s such T aceabili y Managemen o Sys ems o Sys ems 417 as [18] by En íquez e al. and [19] by Pe e sen e al. Ini ially, his me hod was p oposed by Ki chenham e al. [20] and i s goal was o p esen a ai e alua ion o a esea ch opic by using a us wo hy, igo ous, and audi able me hodology. In his con ex , he e o e, ou s udy aims o iden i y and analyze SoS solu ions and heo e ical p oposals o BSM and aceabili y o samples inART p ocesses using e iew me hods men ioned p e iously. Fo his pu pose, we ha e ocused he e iew p ocess in wo a eas: scien i ic ield and indus ial ield. The e iew p ocess in bo h a eas will be ca ied ou ollowing he phases desc ibed by Ki chenham [20]: (i) planning, which con i ms he necessi y o he esea ch, de ines he e iew p o ocol, esea ch ques ions ( he mos impo an ac i i y) and decides how esea che s should ca y ou he e iew; (ii) conduc ing, which execu es he de ined p o ocol p e iously; and (iii) epo ing, which desc ibes how he inal epo has been elabo a ed. Finally, we ha e p oposed wo inc emen al i e a ions in o de o adjus and imp o e ou e iew p o ocol in scien i ic ield and indus ial ield. This decision has allowed o iden i y indus ial, echnical and scien i ic p oposals wi h a b oade scope, p o iding a gene al iew o hem. Then, he i s i e a ion akes in o accoun only some esul s om da asou ces o ob ain a g ea e eedback, which allows us o imp o e e iew p o ocol and sea ch keywo ds. La e , he e iew p ocess is exhaus i ely execu ed in he second i e a ion ollowing all phases p oposed by Ki chenham. Nex sec ions desc ibe in de ail how we ha e conduc ed each phase o achie e ou esea ch goal. Howe e , i is impo an o men ion ha his pape is ocused on p esen ing he inal i e a ion o ou e iew p ocess because i is he mos exhaus i e and comple e i e a ion. 4 Planning he Sys ema ic Re iew This sec ion desc ibes in de ail he planning p ocess ha ha e been ca ied ou in his s udy o scien i ic and indus ial pu poses. Du ing his p ocess, i has been iden i ied he need o pe o ming his e iew, he esea ch ques ions ha e been o mula ed, and he e iew p o ocol has been de ined and alida ed. 424 L. M. T ujillo e al. by checking whe he any o he documen s emaining a e he i s sc eening we e duplica ed, lea ing us wi h a o al o 14 documen s. This was due o he ac ha mos o he documen s ound h ough he di e en sea ch engines we e coinciden . In sho , he inal esul was a o al o 17 p ima y s udies o ead he ull ex . O hese 17 p ima y s udies inally selec ed, 14 belonged o he sea ch p ocess co esponding o 7.57% o he o al esul s ound in he ini ial sea ch and 3 p ima y s udies ha we e ecommended by expe s in he ield. Figu e 2 summa izes he olume o p ima y s udies ha we e ob ained a e applying each selec ion p ocess and inclusion/exclusion c i e ia. On he o he hand, Table 5 shows he o al o selec ed p ima y s udies, ha is, he 17 selec ed p ima y s udies. Figu e 2 P ima y s udies selec ion p ocedu e. T aceabili y Managemen o Sys ems o Sys ems 425 Table 5 P ima y s udies. Scien i ic ield Ti le Re e ence T aceabili y in assis ed ep oduc ion echnology [22] Quali y managemen in he ART labo a o y [23] O e all quali y imp o emen o an IVF cen e: Use ulness o a quali y sys em in ep oduc ion [24] A no el emb yo iden i ica ion sys em by di ec agging o mouse emb yos using silicon-based ba codes [25] Di ec emb yo agging and iden i ica ion sys em by a achmen o bio unc ionalized polysilicon ba codes o he zona pellucida o mouse emb yos [26] Ba code agging o human oocy es and emb yos o p e en mix-ups in assis ed ep oduc ion echnologies [27] T aceabili y o human spe m samples by di ec agging wi h polysilicon mic oba codes [28] Failu e mode and e ec s analysis o wi nessing p o ocols o ensu ing aceabili y du ing IVF [29] Re ised guidelines o good p ac ices in IVF labo a o ies [30] Applica ion o ailu e mode and e ec analysis in an assis ed ep oduc ion echnology labo a o y [31] Failu e mode an a ec s analysis o wi nessing p o ocols o ensu ing aceabili y du ing PGD/PGS cycles [32] Elec onic wi ness sys em in IVF-pa ien s pe spec i e [33] Quali y managemen in he IVF labo a o y: Wi nessing [34] Comp ehensi e p o ocol o aceabili y du ing IVF: The esul o a mul icen e ailu e mode and e ec analysis [35] Di e en ba codes codi ica ion o emb yo mic olabeling [36] De elopmen o a secu i y sys em o assis ed ep oduc i e echnology (ART) [37] Measu ing human e o in he IVF labo a o y using an elec onic wi nessing sys em [38] 5.1.2 Syn hesis o da a This sec ion summa izes he da a ob ained a e execu ing he que ies de ined in he sea ch s a egy sec ion o his documen . In o de o de ine he classi ica ion amewo k o each o he p ima y s udies ound, he 426 L. M. T ujillo e al. p ocedu e app oached was o y o answe each one o he esea ch ques ions o mula ed in he planning o he e iew, and o keep each one o he cha ac e is ics ha de ined i , in such a way ha , o each ques ion, a se ies o cha ac e is ics ha de ine i is ob ained. On he o he hand, wo comple e i e a ions we e ca ied ou o classi y all he s udies and check ha all he cha ac e is ics ha had been ound included he con en o each s udy. Table 6 shows and desc ibes he classi ica ion amewo k ha has been c ea ed based on he 17 p ima y s udies esul ing om he execu ion o he a o emen ioned sea ches, he applica ion o he inclu- sion/exclusion c i e ia and he inco po a ion o s udies ecommended by expe s. Table 6 Cha ac e is ic o classi ica ion. Scien i ic ield Ques ion Cha ac e is ic Desc ip ion RQ1 Me hod and/o echnique This cha ac e is ic de ines whe he he p oposal ha is made in he p ima y s udy is a se o p ocedu es o ob ain a esul . Mic o echnology suppo This cha ac e is ic de ines whe he he p oposal made in he p ima y s udy is a echnology composed o mic ode ices. RQ2 Academic This cha ac e is ic de ines whe he he p oposal made in he p ima y s udy has been alida ed wi h a case s udy a he academic le el. Indus ial This cha ac e is ic de ines whe he he p oposal made in he p ima y s udy has been alida ed wi h any case s udy in indus y. Valida e This cha ac e is ic de ines whe he he p oposal made in he p ima y s udy has been alida ed wi h expe imen s, use cases o su eys. No alida e This cha ac e is ic de ines whe he he p oposal made in he p ima y s udy has no been alida ed wi h expe imen s, use cases o su eys. Expe imen This cha ac e is ic de ines whe he he p oposal made in he p ima y s udy has been alida ed wi h he elabo a ion o di e en expe imen s. (Con inued) T aceabili y Managemen o Sys ems o Sys ems 427 Table 6 Con inued Ques ion Cha ac e is ic Desc ip ion Case o use This cha ac e is ic de ines whe he he p oposal made in he p ima y s udy has been alida ed wi h he s udy o a use case. Su ey This cha ac e is ic de ines whe he he p oposal made in he p ima y s udy has been alida ed wi h he elabo a ion o some ype o su ey. RQ3 Quali y managemen sys em This cha ac e is ic de ines whe he he solu ion p oposed by he p ima y s udy is based on he implemen a ion o a quali y managemen sys em. Silicon ba codes This ea u e de ines whe he he solu ion p oposed by he p ima y s udy is based on he use o silicon ba codes. Bio unc ional polysilicon ba codes This cha ac e is ic de ines whe he he solu ion p oposed by he p ima y s udy is based on he use o bio unc ional polysilicon ba codes. FMEA This cha ac e is ic de ines whe he he solu ion p oposed by he p ima y s udy is based on he applica ion o a p ocess aul iden i ica ion me hodology (FMEA). RFID This ea u e de ines whe he he solu ion p oposed by he p ima y s udy is based on he use o adio equency iden i ica ion (RFID) ags. DMC This cha ac e is ic de ines whe he he solu ion p oposed by he p ima y s udy is based on he applica ion o he double-manual checking (DMC) p o ocol. Guide o good p ac ice This cha ac e is ic de ines whe he he solu ion p oposed by he p ima y s udy is based on he use o good p ac ice guides. RQ4 Compa ison o solu ions This cha ac e is ic de ines whe he he solu ion p oposed by he p ima y s udy is a compa ison o se e al exis ing p oposals in he li e a u e. P oposal o solu ions This cha ac e is ic de ines whe he he solu ion p oposed by he p ima y s udy is a new p oposed solu ion. Imp o ed o solu ions This cha ac e is ic de ines whe he he solu ion p oposed by he p ima y s udy is an imp o emen o an exis ing p oposal in he li e a u e. 428 L. M. T ujillo e al. The esea ch ques ion o which each cha ac e is ic ob ained co e- sponds, i s name o iden i ica ion and a b ie desc ip ion o i s pu pose o na u e a e p esen ed. 5.2 Indus ial Field Once he s udy o indus ial echnologies has been ca ied ou , and he p ima y echnologies ha e been de ec ed and selec ed, he main conclusions ob ained a e shown. The sea ch engines e u n e y ew esul s due o he ac ha his is a a he p ema u e ield in he indus y. I he es ic ion ha hese esul s mus be new compa ed o hose ound in he scien i ic ield is added o his, he esul s ob ained a e u he educed. In addi ion, many o he esul s ob ained h ough he di e en sea ch engines we e coinciden , which esul ed in a g ea e dec ease in he numbe o inal elemen s. Finally, a o al o 5 po en ial esul s we e ob ained o add ess he p oblem o he con ol o biological samples in assis ed ep oduc ion labo a o ies. All he esul s ound a e echnologies o me hods used in indus y oday, whe he o a g ea e o lesse ex en , which is why hey do no appea in he scien i ic ield, since mos o he elemen s ound in ha ield (scien i ic ield) belonged o esea ch ha ocused on he use o me hodologies and di e en suppo s o mic ode ices bu none was a comple e solu ion so hey could no be launched on he ma ke o es ed in he ield o indus y. The classi ica ion applied o ca y ou he syn hesis o he da a ob ained a e ca ying ou he sea ches is ma ked by he esea ch ques ions. The p ocedu e used was he same as ha used o he scien i ic ield (seeTable 6), i consis s o answe ing each o he esea ch ques ions and keeping each one o he cha ac e is ics ha de ined i . Table 7 shows he o al o selec ed p ima y s udies. 6 Repo ing and Discussion This sec ion discusses one by one he answe s o he ou esea ch ques ions de ined as he a ge o ul ill his sys ema ic li e a u e e iew. T aceabili y Managemen o Sys ems o Sys ems 429 Table 7 P ima y s udies. Indus ial ield Name Re e ence RI Wi nessTM [39] Handbook o Good P ac ices [40] SIRHA [41] Gidge [42] IVF Pa ol [43] Figu e 3 Resul s RQ1. Scien i ic ield. RQ1. «Wha me hods, echniques and/o a i ac s/ ools ha e been in es iga ed o he con ol o he aceabili y o biological samples in assis ed ep oduc ion?» The esea ch ques ion RQ1 ocuses on inding me hods, echniques and/o ools ha ha e been in es iga ed o he con ol o he aceabili y o biological samples in assis ed ep oduc ion. Rega ding scien i ic ield, Figu e 3 shows he p edominan ype o s udy a e me hods and/o echniques, which ep esen 52.94% o he o al numbe o s udies. The es o s udies co espond o suppo s o mic o echnologies wi h 47.06%. Rega ding indus ial ield, Figu e 4 shows ha mos esul s co espond o comple e sys ems based on echnology composed o mic o-de ices, wi h 4 elemen s o he o al, he emaining elemen , co espond o p oposed me hodologies. In e ms o pe cen ages, he 430 L. M. T ujillo e al. Figu e 4 Resul s RQ1. Indus ial ield. Figu e 5 Resul s RQ2. Scien i ic ield. comple e sys ems wi h mic o echnology suppo ep esen 80% o he o al o he elemen s and in e ms o he me hod p oposal hey co espond o 20% o he esul s. RQ2. «Wha me hods, echniques and/o ools ha e been used o con ol he aceabili y o biological samples in assis ed ep oduc ion?» The second esea ch ques ion aims o know i esea ch wo ks ound a e p ac ical o heo e ical wo ks. Rega ding scien i ic ield, Figu e 5 shows ha he as majo i y o publica ions belong o he academic ield, speci ically 82.35% o T aceabili y Managemen o Sys ems o Sys ems 431 Figu e 6 Valida ion o academic p ima y s udies. he o al. In addi ion, a e analyzing he p ima y s udies ound in ou sys ema ic e iew, i is possible o iden i y ha mos s udies ha e been alida ed in he academic ield (Figu e 6). Also, ega ding alida ed s udies, h ee g oups ha e been di e en i- a ed (Figu e 7).The i s one (expe imen a ion g oup) e e s o alida ed wo ks by means o expe imen al me hods using es da a o eal da a. This g oup is he one ha con ains he majo i y o he ound esul s ha we e alida ed (61.54% o he o al). The second g oup e e s o a alida ion o he p oposal using use cases o case s udies. The p opo ion o p ima y s udies included in his g oup is 38.46%. Finally, he hi d g oup g oups he p oposals ha ha e been alida ed h ough su eys. In his case, only 7.69% o he s udies analyzed ha e been alida ed wi h his me hod. Rega ding indus ial ield, Figu e 8 shows ha all esul s ob ained a e execu ing he sea ch p o ocol a e p ac ical esul s and, he e o e, hese esul s ha e been classi ied in he indus ial ield. RQ3. «Wha is he na u e o he me hods, echniques and/o ools ound on he con ol o he aceabili y o biological samples in assis ed ep oduc ion?» This esea ch ques ion aims o iden i y he na u e o he me hods, echniques and/o ools ound o con ol he aceabili y o biological samples in assis ed ep oduc ion. 432 L. M. T ujillo e al. Figu e 7 Types o alida ion p ima y s udies. Figu e 8 Resul s RQ2. Indus ial ield. Rega ding scien i ic ield, as can be seen in he Figu e 9, se e al ca ego ies o classi ica ion a e dis inguished. The p edominan ones a e he use o bio unc ional polysilicon ba codes and he applica ion o he me hod o iden i y ac ual o po en ial e o s in he p ocesses (FMEA). Bo h ones ep esen 23.53% o he o al. Nex one is he ca ego y o applica ion o quali y managemen sys ems, wi h 17.65%. The es o he s udies appea in low measu e. Mo eo e , a e analyzing he p ima y s udies in conside a ion o hei na u e, i is possible o iden i y wo g oups: (i) me hods and/o echniques which includes he cha ac e is ics o quali y managemen sys ems, FMEA, MDT and guide o good p ac ices, and (ii) mic ode- ice suppo , which includes RFID ea u es, silicon ba codes and bio unc ional polysilicon ba codes. T aceabili y Managemen o Sys ems o Sys ems 433 Figu e 9 Resul s RQ3. Scien i ic ield. Figu e 10 Resul s RQ3. Indus ial ield. Rega ding indus ial ield, and acco ding o he de ined axonomy, he na u e o he solu ion ha s ands ou is he one ha uses RFID (Figu e 10). In o al 2 elemen s ha e been ob ained in which RFID is used, ep esen ing 40% o he o al. Subsequen ly, he e is a se o na u es ha ob ained a single esul , hese ep esen 20% o he esul s and co espond o he moni o ing o a guide o good p ac ices, a web se ice as an in o ma ion suppo and a sys em in which ba codes a e used o con ol biological samples. The es o he classi ied na u es did no ob ain any esul s o his a ea. Finally, we could in eg a e he esul s ob ained in bo h he scien i ic and indus ial ields in o p ocess-o ien ed managemen . This manage- men has a clea mul idisciplina y cha ac e ha has condi ioned he 440 L. M. T ujillo e al. [11] Cohen, J., Gilligan, A., & Ga isi, J. (2005). Se ing up an ART labo a o y. In Tex book o Assis ed Rep oduc i e Techniques (pp. 37–44). CRC P ess. [12] ESHRE G oup. (2015). Re ised guidelines o good p ac ice in IVF labo a o ies. Guideline o he Eu opean Socie y o Human Rep oduc ion and Emb yology. Eu opean Socie y o Human Rep oduc ion and Emb yology. [13] Tyle , J. P. (2016). Da a Managemen in he ART Uni . In O ganiza ion and Managemen o IVF Uni s (pp. 193–215). Sp inge , Cham. [14] Tho nhill, A. R., B une i, X. O., & y Bi d, S. (2013). Medici´ on de e o es humanos en el labo a o io de FIV median e un sis ema elec ´ onico de obse aci´ on. En el 17◦Cong eso Mundial sob e con o e sias en Obs e icia, Ginecolog´ ıa e In e ilidad (COGI) (p. 101). [15] Commission Di ec i e, (2015). Di ec i e 2006/86/EC as ega ds ce ain echnical equi emen s o he coding o human issues and cells. O icial Jou nal o he Eu opean Union. Commission Di ec i e (EU) 2015/565. ELI:h p://da a.eu opa.eu/eli/di /2015/ 565/oj [16] Coope Su gical Company. RI Wi nessART Managemen Sys em. Websi e: h ps:// e ili y.coope su gical.com/p oduc s/ i-wi ness/ (accessed Feb ua y, 2019). [17] Inebi . Websi e: h ps://inebi .com/en/ (accessed Feb ua y, 2019). [18] En ´ ıquez, J. G., Dom´ ınguez-Mayo, F. J., Escalona, M. J., Ross, M., & S aples, G. (2017). En i y econcilia ion in big da a sou ces: A sys ema ic mapping s udy. Expe Sys ems wi h Applica ions, 80, 14–27. [19] Pe e sen, K., Feld , R., Muj aba, S., & Ma sson, M. (2008, June). Sys ema ic mapping s udies in so wa e enginee ing. In Ease (Vol. 8, pp. 68–77). [20] Ki chenham, B., & B e e on, P. (2013). A sys ema ic e iew o sys ema ic e iew p ocess esea ch in so wa e enginee ing. In o ma ion and So wa e Technology, 55(12), 2049–2075. h p://doi.o g/10.1016/j.in so .2013.07.010. [21] S. Feye , S. Siebe , B. Gipp, A. Aizawa, & J. Beel, In eg a- ion o he scien i ic ecommende sys em M . DLib in o he T aceabili y Managemen o Sys ems o Sys ems 441 e e ence manage JabRe , in: Lec . No es Compu . Sci. (Including Subse . Lec . No es A i . In ell. Lec . No es Bioin o ma ics), 2017. doi:10.1007/978-3-319-56608-5 80. [22] L. La ue, T aceabili y in assis ed ep oduc i e echnology, And ologie. 29 (2000) 384–387. [23] P. M. M. Kas op, Quali y managemen in he ART labo a o y, Rep od. Biomed. Online. 7 (2003) 691–694. [24] R. Nunez-Calonge, S. Co es, B. Pe amo, & P. Caballe o, O e all quali y imp o emen o an IVF cen e: Use ulness o a quali y sys em in ep oduc ion, In . Cong . Se . (2004). doi:10.1016/j.ics.2004.04.007. [25] S. No o, L. Ba ios, J. San al, R. Gmez-Ma nez, M. Duch, J. Es e e, J. A. Plaza, C. Nogus, & E. Ibez, A no el emb yo iden i ica ion sys em by di ec agging o mouse emb yos using silicon-based ba codes, Hum. Rep od. (2011). doi:10.1093/hum ep/deq309. [26] S. No o, O. Penon, L. Ba ios, C. Nogu´ es, J. San al´ o, S. Du ´ an, R. G´ omez-Ma ´ ınez, J. Sami ie , J. A. Plaza, L. P´ e ez-Ga c´ ıa, & E. Ib´ a˜ nez, Di ec emb yo agging and iden i ica ion sys em by a achmen o bio unc ionalized polysilicon ba codes o he zona pellucida o mouse emb yos, Hum. Rep od. (2013). doi:10.1093/hum ep/de 083. [27] S. No o, C. Nogu´ es, O. Penon, L. Ba ios, J. San al´ o, R. G´ omez-Ma ´ ınez, J. Es e e, A. E achid, J.A. Plaza, L. Pˆ e ez- Ga c´ ıa, & E. Ib´ a˜ nez, Ba code agging o human oocy es and emb yos o p e en mix-ups in assis ed ep oduc ion echnologies, Hum. Rep od. (2014). doi:10.1093/hum ep/de 409. [28] S. No o, I. Mo a-Esp´ ı, R. G´ omez-Ma ´ ınez, L. Ba ios, E. Ib´ a˜ nez, X. Such, M. Duch, X. Mo a, J.A. Plaza, & C. Nogu´ es, T aceabili y o human spe m samples by di ec agging wi h polysilicon mic oba codes, Rep od. Biomed. Online. (2015). doi:10.1016/j. bmo.2015.04.012. [29] L. Rienzi, F. Ba iani, M. Dalla-Zo za, S. Romano, C. Sca ica, R. Maggiulli, A. Nanni-Cos a, & F. Ubaldi, Failu e mode and e ec s analysis o wi nessing p o ocols o ensu ing aceabili y du ing IVF, Rep od. Biomed. Online. (2015). 442 L. M. T ujillo e al. [30] M. De los San os, S. Ap e , G. Co icchio, S. Deb ock, K. Lundin, C. Plancha, F. P ados, L. Rienzi, G. Ve heyen, B. Woodwa d, & N. Ve meulen, Re ised guidelines o good p ac ices in IVF labo a o ies, Hum. Rep od. (2015). [31] G. In a, A. Al e i, L. Co i, E. Rabello i, E. Papaleo, L. Res elli, S. Biondo, M. P. Ga ancini, M. Candiani, & P. Vigan` o, Applica ion o ailu e mode and e ec analysis in an assis ed ep oduc ion echnology labo a o y, Rep od. Biomed. Online. (2016). doi:10.1016/j. bmo.2016.05.008. [32] D. Cimadomo, F. M. Ubaldi, A. Capalbo, R. Maggiulli, C. Sca ica, S. Romano, C. Poggiana, D. Zucca ello, A. Giancani, A. Vaia elli, & L. Rienzi, Failu e mode and e ec s analysis o wi nessing p o ocols o ensu ing aceabili y du ing PGD/PGS cycles, Rep od. Biomed. Online. (2016). doi:10.1016/j. bmo.2016. 06.002. [33] M. Fo e, F. Faus ini, R. Maggiulli, C. Sca ica, S. Romano, C. O olini, A. Fa comeni, A. Palagiano, A. Capalbo, F. Ubaldi, & L. Rienzi, Elec onic wi ness sys em in IVF-pa ien s pe spec i e., J. Assis . Rep od. Gene . (2016). [34] D. H. McCulloh, P. A. Labella, & C. McCa ey, Quali y manage men in he IVF labo a o y: Wi nessing, in: P inc. IVF Lab. P ac . Op im. Pe o m. Ou comes, 2017. doi:10.1017/9781316569 238.040. [35] L. Rienzi, F. Ba iani, M. Dalla Zo za, E. Albani, F. Benini, S. Chamayou, M.G. Minasi, L. Pa megiani, L. Res elli, G. Vizziello, & A. N. Cos a, Comp ehensi e p o ocol o aceabili y du ing IVF: The esul o a mul icen e ailu e mode and e ec analysis, Hum. Rep od. (2017). doi:10.1093/hum ep/dex144. [36] R. G´ omez-ma ´ ınez, S. No o, M. Duch, L. Ba ios, E. Iba˜ nez, C. Nogues, J. Es e e, & J.A. Plaza, Di e en ba codes codi ica ion o emb yo mic olabeling, 14 h In . Con . Minia u ized Sys . Chem. Li e Sci. (2010). [37] Y. S. Hu , E. K. Ryu, S. J. Pa k, J. Yoon, S. H. Yoon, G. D. Yang, C. Y. Hu , W. D. Lee, & J. H. Lim, De elopmen o a secu i y sys em o assis ed ep oduc i e echnology (ART), J. Assis . Rep od. Gene . (2015). doi:10.1007/s10815-014-0367-0. T aceabili y Managemen o Sys ems o Sys ems 443 [38] A. R. Tho nhill, X. B une i-O iols, & S. Bi d, Measu ing human e o in he IVF labo a o y using an elec onic wi nessing sys em, WORLD Cong . Con o . Obs e . Gynecol. In e il. (n.d.). [39] Coope Su gical Fe ili y Companies, RI Wi ness, (n.d.). h ps:// www.o igio.com/p oduc s/ i-wi ness/ (accessed Feb ua y, 2019). [40] A. de la Fuen e, M. Boada, A. Reche, M. Mu˜ noz, M. Ma ´ ınez- Moya, M. Nicol´ as, J. Ma que a, J. Mozas, I. A no , F. Abell´ an, J. Nadal, L. Fei o, & A. Romeu, J. Ballesc´ a, Manual de buenas p ´ ac icas, 144 (2016). [41] Minis e io de sanidad consumo y bienes a social, Gabine e de P ensa - No as de P ensa, (n.d.). h ps://www.mscbs.gob.es/ gabine e/no asP ensa.do?id=4223 (accessed Feb ua y, 2019). [42] Me ck, Gidge : an elec onic wi ness & wo k low solu ion o labs, (n.d.). h ps://hcp.me ckg oup.com/en/ e ili y/ echnolo gies/Gidge .h ml? (accessed Feb ua y, 2019). [43] GineFi , IVF Pa ol. Segu idad o al en u a amien o de e ilidad, (n.d.). h ps://www.gine i .com/i -pa ol (accessed Feb ua y, 2019). [44] Shewha , Wal e And ew; DEMING,William Edwa ds. S a is ical me hod om he iewpoin o quali y con ol. Cou ie Co po a ion, 1986. [45] Blanco, R., En ´ ıquez, J. G., Dom´ ınguez-Mayo, F. J., Escalona, M. J., & Tuya, J. (2018). Ea ly In eg a ion Tes ing o En i y Reconcilia ion in he Con ex o He e ogeneous Da a Sou ces. IEEE T ansac ions on Reliabili y, 67(2), 538–556. [46] En ´ ıquez, J. G., Oli e o, M., Escalona, M. J., & Mej´ ıas, M. (2018). MARIA: A P ocess o Model En i y Reconcilia ion P oblems. J. Web Eng., 17(3&4), 206–223. [47] Dom´ ınguez-Mayo, F. J., Escalona, M. J., Mej´ ıas, M., Ross, M., & S aples, G. (2014). Towa ds a homogeneous cha ac e iza ion o he model-d i en web de elopmen me hodologies. Jou nal o web enginee ing, 13(1-2), 129–159. [48] Escalona, M. J., Gu i´ e ez, J. J., P´ e ez-P´ e ez, M., Molina, A., Dom´ ınguez-Mayo, E., & Dom´ ınguez-Mayo, F. J. (2011). Mea- su ing he quali y o model-d i en p ojec s wi h NDT-Quali y. In In o ma ion Sys ems De elopmen (pp. 307–317). Sp inge , New Yo k, NY. 444 L. M. T ujillo e al. Biog aphies Le icia Mo ales T ujillo holds a Bachelo ’s Deg ee in Heal h Engi- nee ing wi h a men ion in Biomedical Enginee ing om he Uni e si y o Se ille since 2016 and a Mas e ’s Deg ee in So wa e Enginee ing and Technology om he Uni e si y o Se ille since 2018. Since 2016 esea che associa ed o he esea ch g oup o Web Enginee ing and Ea ly Tes ing (IWT2), belonging o he Depa men o Languages and Compu e Sys ems o he Uni e si y o Se ille. Cu en ly, she is en olled in he doc o al p og am 2018-2019 o he Uni e si y o Se ille. A he esea che le el he has pa icipa ed in se e al esea ch p ojec s a a na ional le el. Among i s mos impo an esea ch esul s a e se e al con ibu ions o na ional and in e na ional con e ences and publica ions in JCR jou nals. Julián Albe o Ga cía was awa ded his PhD in Compu e Science by he Uni e si y o Se ille, Spain, in 2015. Since 2008, he has pa icipa ed in R&D p ojec s as a esea che in he Web Enginee ing and Ea ly Tes ing G oup (IWT2). He cu en esea ch in e es s include he a eas o p ope y enginee ing, Business P ocess Managemen (BPM), Model- D i en Enginee ing and quali y assu ance. Julian is esponsible o he BPM a ea and esponsible o secu i y o in IWT2. He is lec u e in T aceabili y Managemen o Sys ems o Sys ems 445 he Uni e si y o Se illa (Spain) and manages se e al echnological ans e p ojec s wi h companies and he pa icipa es as a membe comi ee in se e al in e na ional cong esses and jou nals. Da id Lizcano holds a Ph.D. in Compu e Science (2010) and a M.Sc. in Resea ch in Complex So wa e De elopmen (2008) om he Uni e sidad Poli écnica de Mad id, UP. He is P o esso a Mad id Open Uni e si y, UDIMA. He held a esea ch g an om he Eu opean Social Fund, and was in ol ed in se e al na ional and Eu opean- unded p ojec s ela ing o se ice-o ien ed a chi ec u es, p og amming pa adigms, so wa e enginee ing, human-compu e in e ac ion and end-use de elopmen . He has published his esea ch in mo e han 30 high- anking JCR-indexed jou nals. Manuel Mejías was awa ded his Ph.D in Indus ial Enginee ing by he Uni e si y o Se ille, Spain, in 1997. He has been a lec u e a his uni e si y since 1987, whe e he is cu en ly a lec u e and esea che . He has been se e al yea s eaching and esea ching in he ield o So wa e Enginee ing. His cu en lines o esea ch a e plo ed in he a eas o me hodological issues in so wa e p ocess, quali y assu ance and e e ence models in so wa e p oduc ion.