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.
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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.