GoodDocument

ati
onPr
act
icesandDat
aInt
egr
it
y
1.Pr
inci
plesofGoodDocument
ati
onPr
act
iceandDat
aInt
egr
it
y
 ALCOA+Framewor k:
Attr
ibut
abl
e,Legibl
e,Cont
empor
aneous,
Ori
ginal
,Accur
ate,
Complet
e,Consi
stent,
Enduri
ng,
Av ai
l
able.

 DataGover
nance:I
ntegrat
edi
ntot
hePhar
maceut
ical
Qual
i
tySy
stem,
wit
hdef
ined
rol
esandresponsi
bil
i
ties.

 ManagementCommitment
:Seni
orl
eader
shi
pensur
esqual
i
tycul
tur
e,t
ranspar
ent
r
eport
ing,
andethi
cal
behavi
or.

 RiskManagement(ICHQ9):Assessdat
acr
it
ical
i
tybasedonqual
i
ty/
saf
etyi
mpact
andappl
yproport
ionatecont
rol
s.

 Syst
em Desi
gn:Prev
entmani
pul
ati
on,
rest
ri
ctaccess,
enabl
eaudi
ttr
ail
s,and
conductr
out
ineaudi
ts.

 Regul
ator
yAl
ignment:Complywit
hFDA,
WHO,
PIC/
S,andMHRAexpect
ati
onsf
or
rel
i
abl
eandreconst
ructabl
edata.

2.I
nst
ructi
ons,Bl
ankFor
ms,
andRecor
ds–Li
feCy
cleandDat
aInt
egr
it
y
Consi
derat
ions
 Dat
aCr
it
ical
i
tyCat
egor
izat
ion:
UseFMEAorsi
mil
art
ool
stodef
inecont
rol
lev
els.

 Bl
ankForms&Templ
ates:
Uni
quei
dent
if
ier
s,v
ersi
oncont
rol
,ful
lreconci
l
iat
ionf
or
hi
gh-
cri
ti
cal
i
tyf
orms.

 Li
fecy
clePhases:
Dat
acapt
ure→ st
orage→ changes→ ar
chi
val
→ di
sposal
.

 Cont
rol
s:Paper(i
ndel
ibl
eink,si
ngl
e-l
i
necor
rect
ions)
,El
ect
roni
c(v
ali
dat
edsy
stems,
audi
ttr
ail
s,r
ole-
basedaccess).

 Remediat
ion&CAPA:I
dent
if
yvul
ner
abi
l
iti
est
hroughgapassessment
sandappl
y
cor
rect
iveact
ions.

 Dur
abi
l
ity
:Secur
est
orage,
met
adat
aret
ent
ion,
cer
ti
fi
edt
ruecopi
eswher
eneeded.

3.GoodDocumentat
ionPr
act
icesf
orLi
nkedPaperandEl
ect
roni
c
Recor
ds(Hybr
id)
 PaperRecor
ds:
Indel
i
blei
nk,
cont
empor
aneousent
ri
es,
just
if
iedcor
rect
ions.

 El
ect
roni
cRecor
ds:
Val
i
dat
edsy
stems,
dynami
cdat
aret
ent
ion,
audi
ttr
ail
s.
 Hybri
dRecords:
Qual
i
fymanual
int
erf
aces,
ret
ainor
igi
nal
s,andensur
efour
-ey
e
ver
if
icat
ion.

 Ri
sk-BasedContr
ols:
Aut
omat
ionf
orhi
gh-
cri
ti
cal
i
tydat
a,peerchecksf
orl
ower
-
cr
it
ical
it
ydata.

 Secur
it
y:Accessr
est
ri
cti
ons,
backups,
andper
iodi
caudi
ttr
ail
rev
iews.

 Ov
ersi
ght
:SOPsandQAr
evi
ewt
opr
eventunaut
hor
izedchanges.

4.Per
for
mingSecondPer
sonRev
iewofBat
chRecor
dsi
nDi
ff
erent
Format
s
 Trai
ning:Rev
iewersmustunder
standALCOA+,
syst
em-
speci
fi
cri
sks,
and
fal
sif
icat
iondetect
ion.

 PaperRevi
ew:Checkcompl
eteness,
cal
cul
ati
ons,
att
achment
s;wi
tnesscr
it
ical
steps
i
fnecessar
y.

 Hybri
dRevi
ew: Veri
fyt
ranscr
ipt
ionaccur
acyandl
i
nkedel
ement
s;usephot
ogr
aphi
c
ev
idencei
frequir
ed.

 El
ectr
onicRev
iew:
Audi
ttr
ail
checksal
ongsi
der
ecor
dst
oconf
ir
m accur
acyand
i
ntegr
it
y.

 Ri
sk-BasedRevi
ew:
Ful
lrev
iewf
orhi
gh-
cri
ti
cal
i
tydat
a,sampl
i
ngr
evi
ewf
orl
ower
-
cr
it
ical
it
ydata.

 Escal
ati
on:Documentfi
ndi
ngs,r
epor
tfal
sif
icat
ionsuspi
cions,
andt
rack
eff
ect
ivenesst
hroughaudi
ts.

5.Tr
aini
ngSt
affi
nGoodDocument
ati
onPr
act
iceandDat
aInt
egr
it
y
 Pol
i
cy:
Trai
ningr
equi
redf
oral
lrol
es.

 Cont
entbyRole:Basi
csf
oral
lst
aff
;adv
anced(
audi
ttr
ail
s,sy
stem cont
rol
s)f
or
anal
yst
s/super
visor
s.

 Tr
aini
ngMet
hods:
Inst
ruct
or-
ledsessi
ons,
pract
ical
exer
cises,
ethi
cal
casest
udi
es.

 Ef
fect
ivenessAssessment
:Qui
zzes,
audi
ts,
sel
f-
inspect
ions.

 Conti
nuousI
mpr ovement
:Per
iodi
cref
resher
s,onboar
dingi
ntegr
ati
on,
anony
mous
repor
ti
ngchannels.

6.DocumentCont
rol
ProcessFl
ow
 Cont
rol
ledManagement
:Documentcr
eat
ion→ appr
oval
→ di
str
ibut
ion→ change
cont
rol
.
 Ri
skMappi
ng:
Ident
if
yri
sksandi
nter
facesusi
ngpr
ocessf
lowchar
ts.

 Mult
il
ingual
Cont
rol
s:Dr
aft
ing,
transl
ati
on,
synchr
oni
zat
ion,
andGMP-
stat
us
assi
gnment.

 Ongoi
ngOv
ersi
ght
:Regul
arr
evi
ews,
ver
sioncont
rol
,andqual
i
tysy
stem i
ntegr
ati
on.