Taket

hefirstst
e psto
c
api
tali
zeonthebenefitsof
ComputerSof
twar
e
Assur
ance(
CSA)
L
ear
nmor
eaboutCS
Aatus
dm.
com

Whati
sCSA?
In2011, t
heFDA’ sCent erforDevi cesandRadi ol
ogicalHeal t
h( CDRH)initiatedtheCasef orQuali
ty,
anewpr ogram
thatidenti
fiedbar r
iersinthecur r
entVal i
dati
onofSof t
war einMedi calDevi cesguidance(rel
easedin2002).The
currentguidancefocusesonsof t
war e,whichisanintegralpar tofthemedi caldevicebutdoesnotclearl
yaddress
themanysyst emst hatsuppor tthequal i
tyofamedi caldevice.TheCDRHi swor ki
ngonanewdr aftgui
dance,
“Comput erSof t
wareAssur ancef orManuf acturi
ng,Operations,andQual itySystem Software,
”thatwil
lenable
manuf acturer
st omi ni
mizet heirexisti
ngcomput ersystem v ali
dati
on(CSV)ef f
ortsanddocument ati
onburdent o
focusonmor eefficientprocesses, incl
udingautomat i
on, t
oi mpr ov
eov erallquali
ty.Thi
sguidanceisfoundedona
truerisk-
basedappr oachthatmustbeconsi der
edwhendepl ngnon-
oyi productsof t
waresystems.

CS
A CS
A
Hi
ghl
i
ght
s Be
net
s

•GuidanceonFDA' sAlistforr
eleaseinSeptember2020 •I
mpr ovequali
tyandef ficiency
•CDRHgui dancefortesti
ngofcomput eri
zedsystemsin •Over50%decr easeinv al
idati
oncostandt i
me
cooperati
onwi t
hCBERandCDER •Upto90%f ewert estscri
ptissues
•Non-productquali
tysystem softwar
e(i.
e.,
ERP,LIMS, •Si
gnificanttesti
ngov erheadreducti
on
LMS, eDMS, andQMSaswel lassoftwaretool
s) •Uti
li
zati
onofv endorassur anceacti
vit
ies
•Pri
ncipl
esandappr oachesareappl i
cabl
enowt oall •MaximizetheuseofCSVandI Tresources
regulat
edorganizat
ions •Capabil
it
ytodel i
vervaluefaster

USDM canhel
pyougetf
rom CSVt
oCSA

Fr
om CSV ToCSA
Focusondocument
ingr
ecor
dsf
orcompl
iance Focusont
est
ingf
orhi
ghersyst
em per
for
mance

Ov
er-
val
idat
eev
eryt
hing(
andmi
sshi
gherr
iskar
eas) Appl
yther
ightl
evelofr
igorf
ort
hel
evelofr
isk

I
gnor
epr
evi
ousassur
anceact
ivi
tyorr
elat
edr
iskcont
rol
s Ut
il
iz
epr
iorv
endorassur
anceact
ivi
ty

Ov
eruseofscr
ipt
edt
est
ing Appr
opr
iat
euseofscr
ipt
edandunscr
ipt
edt
est
ing

80%document
ati
on/20%t
est
ing 20%document
ati
on/80%t
est
ing
 CSA
How USDM
Sol
uti
ons
CanHelpToday
Thecompetit
iveadv
ant
agesprovi
dedbycloudsystemsandar i
sk-basedmethodol
ogyarecl
ear.The
FDAhasclearl
ystat
edt
hatwhiletheCSAguidancewil
lber
eleasedlatert
hisy
ear,t
hepr
inci
plesand
methodol
ogycanbeappli
edtoday.

CS
AEduc
ati
on&T
rai
ni
ng
US
DMc
anhe
lpt
rai
nyour
tea
msonCS
Apr
inc
ipl
esa
ndhowt
oappl
ycr
it
ic
alt
hink
ingt
oyour
proc
ess
•Incr
easeawar enessandknowledgeaboutCSApr inci
plesandbenefit
s
•One-offcourses,r
eoccurr
ingt
raini
ng,GxPtrai
ningforsuppli
ers,
andmor
e
•Trai
ningcustomizedtoyourbusinessneedsandpr ocesses
•Onsit
eorr emoteprograms

CS
AAs
ses
sme
nts
USDMcanas
sessy
ourCSVproc
essa
ndrecomme ndCSAcha
ngesbase
donyour
qua l
i
ty
of
document
ati
on,t
est
ing,
SOPs/
WIs
,te
sti
ng,us
eof a
utomat
ion,
per
for
manc
eona udi
ts
,et
c.
•Eval
uateyourcurrentCSVprocessforquickwi
nsandl onger
-ter
mimpr
ovement
s
•Pri
orit
izer
ecommendedchangesbasedonbusi nessjusti
ficat
ion
•Improveyourvendorqual
ificat
ionprocess
•Buil
daCSAr oadmapbasedony ourbusinesspr
iori
ti
es

CS
AMe
thodol
ogy&E
xec
uti
on
F
romv e
ndor
sele
cti
ontomet
hodol
ogyde
vel
opmenttoend-
user
tra
ini
ng,US
DMc an
t
rans
for
myourCSVi
ntoaCS
Aa ppr
oac
handhel
pdri
veadopt
ionacr
ossy
ourorga
niz
ati
on
•I
mplementf ast
-star
timpr ov
ementstoy
ourprocesses
•Dev
el opandexecutepilotpr
ograms
•Del
ivercompleteoverhaulstoy
ourCSVprocessesandpr
ocedur
es

Cl
oudAs
sur
anc
e
US
DMc a
nma na
geyourent
ir
eCSVorCSAproc
essanddel
i
veranend-t
o-e
ndGx Pcompl
iant
mana
gedse
rvi
ce,
inc
ludi
ngthec
onti
nuousmai
ntenanc
eofal
lyourc
loudvendorr
ele
ase
s
•Assistwit
hcloudv endorselect
ionandRFPprocess
•Managecl oudvendorassuranceandmai nt
ainnewrel
eases
•Leverageautomatedregressiontest
ing

Whatar
eyouwai
ti
ngf
or?
Cont
actusat888.
231.
0816orc
ompl
i
anc
e@us
dm.
com

RC_
SO010A