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SOCRA Exam Questions With Complete Solutions
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SOCRA Exam Questions With CompleteSolutions
Electronic nnsignature nnare nncurrently nnaccepted nnfor nnany nnand nnall nnrecords, nnpaper nnor nnelectronic nnform.
nnTrue nnor nnFalse? nn- nnANSWER: nn✔ nnFalse. nnThe nngeneral nnprovisions nnfor nnelecteonic nnsignature nncriteria
nnapply nnto nnrecords nnthat nnare nn
i. nnCreated, nnmodified, nnmaintained, nnarchived, nnretrieved, nnor nntransmitted, nnin nnelectronic nnform
ii. nnThe nncriteria nndo nnnot nnapply nnto nnpaper nnrecords nnthat nnare nnor nnhave nnbeen nntransmitted nnby
nnelectronic nnmeans.
If nnthe nnelectronic nnrecords nnmeet nnthe nncriteria nnspecified nnin nn21 nnCFR nn11, nnthr nnagency nnwill nnconsider
nnthe nnelectronic nnsignatures, nninitials, nnand nnother nngeneral nnsigning nnequivalent nnto nnfull nnhandwritten
nnsignatures, nnunless nnspecifically nnexcepted nnby nnregulations nneffective nnafter nnAugust nn20, nn1997. nnTrue nnor
nnFalse? nn- nnANSWER: nn✔ nnTrue
Electronic nnrecords nncannot nnbe nnused nnin nnlieu nnof nnpaper nnrecords. nnTrue nnor nnFalse? nn- nnANSWER: nn✔
nnFalse. nn
Electronic nnrecords nnthat nnmeet nnthe nnrequirements nnmay nnbe nnused nnin nnlieu nnof nnpaper nnforms, nnunless
nnpaper nnrecords nnare nnspecifically nnrequired.
provisions nnare nnsubject nnto nnwhose nninspection? nn- nnANSWER: nn✔ nnThe nnFDA's nninspection
Provided nnthey nnmeet nnthe nnrequirements, nnpersons nncan nnuse nnelectronic nnrecords nnlieu nnof nnpaper
nnrecords, nnfor nnrecords nnrequired nnto nnbe nnmaintained, nnbut nnnot nnsubmitted nnto nnthe nnagency. nnTrue nnor
nnFalse? nn- nnANSWER: nn✔ nnTrue.
,Persons nncan nnuse nnelectronic nnrecords nnin nnlieu nnof nnpaper nnrecords nnfor nndocuments nnrequired nnto nnbe
nnsubmitted nnto nnthe nnagency nnprovided nnthe nndocument nnhas nnbeen nnidentified nnas nna nntype nnof
nnsubmission nnthat nnthe nnFDA nnwill nnaccept nnin nnelectronic nnformat. nnT nnor nnF? nn- nnANSWER: nn✔ nnTrue.
Documents nnsubmitted nnto nnthe nnFDA nnthat nnare nnnot nnspecified nnin nnthe nnpublic nndocket nnas nnacceptable
nnin nnelectronic nnform, nnwill nnnot nnbe nnconsidered nnas nnofficial nnif nnthey nnare nnsubmitted nnin nnelectronic
nnform. nnT nnor nnF? nn- nnANSWER: nn✔ nnTrue
Who nndetermines nnthe nndetails nnfor nnelectronic nnsubmission nn(e.g. nnmethods nnof nntransmission, nnmedia,
nnfile nnformats nnand nntechnical nnprotocol)? nn- nnANSWER: nn✔ nnThe nnintended nnreceiving nnagency nnunit nnwill
nndetermine nnthe nndetails nnof nnelectronic nnsubmission.
In nnthe nnFDA's nnregulations nncovering nnelectronic nnsignatures, nnwhat nndoes nnthe nnterm nnAct nnrefer nnto? nn-
nnANSWER: nn✔ nnAct nnmeans nnthe nnFederal nnFood, nnDrug nnand nnCosmetic nnAct.
In nnthe nnFDA's nnElectronic nnSignatures nnregulation, nnwhat nndoes nnthe nnterm nnagency nnrefer nnto? nn-
nnANSWER: nn✔ nnAgency nnrefers nnto nnthe nnFood nnand nnDrug nnAdministration
What nnis nnthe nnterm nnthat nnmeans nna nnmethod nnof nnverifying nnan nnindividual's nnidentity nnbased nnon
nnmeasurement nnof nnthe nnindividual's nnphysical nnfeature(s) nnor nnrepeatable nnactions(s) nnwhere nnthose
nnfeatures nnand/or nnactions nnare nnboth nnmeasurable nnand nnunique nnto nnthat nnindividual? nn- nnANSWER: nn✔
nnBiometrics
What nndoes nnthe nnterm nnclosed nnsystem nnmean nnwith nnregard nnto nnelectronic nnrecords? nn- nnANSWER: nn✔
nnClosed nnsystem nnmeans nnenvironment nnin nnwhich nnsystem nnaccess nnis nncontrolled nnby nnpersons nnwho nnare
nnresponsible nnfor nnthe nncontent nnof nnthe nnelectronic nnrecords nnthat nnare nnin nnthe nnsystem.
An nnelectronic nnsignature nnis nnbased nnupon nncryptographic nnmethods nnof nnoriginator nnauthentication,
nncomputed nnby nnusing nna nnset nnof nnrules nnand nna nnset nnof nnparameters nnsuch nnthat nnthe nnidentity nnof nnthe
nnsigner nnand nnthe nnintegrity nnof nnthe nndata nncan nnbe nnverified. nnT nnor nnF? nn- nnANSWER: nn✔ nnFalse. nn
This nnis nnthe nndefinition nnfor nnthe nnterm nndigital nnsignature.
,Any nncombination nnof nntext, nngraphics, nndata, nnpictorial, nnaudio, nnor nnother nninformation nnrepresentation
nnin nndigital nnform nnthat nnis nncreated, nnmodified, nnmaintained, nnarchived, nnretrieved, nnor nndistributed nnby nna
nncomputer nnsystem nnis nnknown nnas nnwhat? nn- nnANSWER: nn✔ nnElectronic nnRecord.
Electronic nnsignature nnand nndigital nnsignature nnare nnsynonymous nnterms. nnor nnF? nn- nnANSWER: nn✔ nnFalse. nn
Electronic nnsignature nnmeans nna nncomputer nndata nncomplilatiom nnof nnany nnsymbol nnor nnseries nnof nnsymbols
nnexecuted nnand nnauthorized nnby nnan nnindividual nnto nnbe nnthe nnlegally nnbinding nnequivalent nnof nnthe
nnhandwritten nnsignature. nnA nndigital nnsignature nnis nnbased nnupon nncryptographic nnmethods nnor nnoriginator
nnauthentication, nna nnset nnof nncomputed nnby nnusing nnrules nnand nna nnset nnof nnparameters nnsuch nnthat nnthe
nnidentity nnof nnthe nnsigner nnand nnthe nnintegrity nnof nnthe nndata nncan nnbe nnverified.
What nntype nnof nnsignature nnis nnthe nnscripted nnname nnor nnlegal nnmark nnof nnan nnindividual nnpreserved nnwith nna
nnwriting nnor nnmarking nninstrument nnsuch nnas nna nnpen nnor nnstylus? nn- nnANSWER: nn✔ nnHandwritten nnsignature
How nndoes nnopen nnsystem nndiffer nnfrom nnclosed nnsystem nnwith nnregards nnto nnthe nnFDA's nnElectronic
nnRecords nnregulations? nn- nnANSWER: nn✔ nnIn nnan nnopen nnsystem nnaccess nnis nnnot nncontrolled nnby nnpersons
nnwho nnare nnresponsible nnfor nnthe nncontent nnof nnelectronic nnrecords nnthat nnare nnon nnthe nnsystem
Why nnis nnvalidation nnof nnsystems nnan nnimportant nnprocedure nnand nncontrol nnfor nnclosed nnsystems? nn-
nnANSWER: nn✔ nnValidation nnof nnsystems nnensures nnaccuracy, nnreliability, nnconsistency nnof nnintended
nnperformance, nnand nnthe nnability nnto nndiscern nninvalid nnor nnaltered nnrecords
The nnability nnto nngenerate nncomplete nnand nnaccurate nncopies nnof nnrecords nnin nnboth nnhuman nnreadable nnand
nnelectronic nnform nnsuitable nnfor nninspection, nnreview, nnand nncopying nnby nnthe nnagency nnis nna nncontrol
nnestablished nnfor nnclosed nnsystems. nnT nnor nnF? nn- nnANSWER: nn✔ nnTrue.
Closed nnsystems nnare nnlimited nnto nnauthorized nnindividuals nnonly. nnT nnor nnF? nn- nnANSWER: nn✔ nnTrue.
21. nnA nnprocedure nnin nnplace nnas nna nncontrol nnfor nnclosed nnsystems nnincludes nnthe nnuse nnof nnsecure,
nncomputer-generated, nntime-stamped nnaudit nntrails nnto nnindependently nnrecord nnthe nndate nnand nntime nnof
nnoperator nnentries. nnChanges nnmade nnto nnthe nnrecords nnmay nnobscure nnand nndelete nnprevious nnrecorded
nninformation, nnso nnthat nnthe nnmost nncurrent nninformation, nnwill nnalways nnbe nnaccessible. nnT nnor nnF? nn-
nnANSWER: nn✔ nnFalse. nn
, Record nnchanges nnshall nnnot nnobscure nnpreviously nnrecorded nninformation.
In nnelectronic nnrecords, nnwhat nndo nnauthority nnchecks nnensure? nn- nnANSWER: nn✔ nnAuthority nnchecks
nnensure nnthat nnonly nnauthorized nnindividuals nncan nnuse nnthe nnsystem, nnelectronically nnsign nna nnrecord,
nnaccess nnthe nncomputer nnsystem's nninput nnand nnoutput nndevices, nnalter nna nnrecord, nnor nnperform nnother
nnoperations nnat nnhand.
A nncontrol nnprocedure nnfor nnclosed nnsystems nnrequires nnthe nndetermination nnthat nnpersons nnwho nndevelop,
nnmaintain nnor nnuse nnelectronic nnrecord/electronic nnsignature nnsystems nnhave nnthe nnproper nntraining,
nneducation nnand nnexperience nnto nnperform nnthe nnassigned nntask. nnT nnor nnF? nn- nnANSWER: nn✔ nnTrue.
Persons nnor nnorganizations nndesiring nnto nnuse nnelectronic nnrecords nnare nnnot nnrequired nnto nnhave nnwritten
nnpolicies nnthat nnhold nnindividuals nnaccountable nnand nnresponsible nnfor nnactions nninitiated nnunder nnthe
nnelectronic nnsignatures, nnbecause nnthe nnnature nnof nnelectronic nnrecords nndoes nnnot nnpermit nnfalsification.
nnT nnor nnF? nn- nnANSWER: nn✔ nnFalse
Persons nnwho nnuse nnopen nnsystems nnare nnnot nnbound nnto nnany nnof nnthe nncontrols nnor nnprocedures
nnestablished nnby nnthe nnclosed nnsystem. nnT nnor nnF? nn- nnANSWER: nn✔ nnFalse,
What nnthree nnelements nnare nnnecessary nnfor nnsigned nnelectronic nnrecords? nn- nnANSWER: nn✔ nna. nnThe
nnprinted nnname nnof nnthe nnsigner nn
b. nnThe nndate nnand nntime nnwhen nnthe nnsignature nnwas nnexecuted. nn
c. nnThe nnmeaning nnof nnthe nnsignature nn(such nnas nnreview, nnapproval, nnauthorship).
Why nnis nnit nnnecessary nnto nnlink nnelectronic nnsignatures nnand nnhandwritten nnsignatures nnto nnthe
nnappropriate nnelectronic nnrecords? nn- nnANSWER: nn✔ nnLinking nnensures nnthat nnthe nnsignatures nncannot nnbe
nnexcised nncopied, nnor nnotherwise nntransferred nnto nnfalsify nnan nnelectronic nnrecord nnby nnordinary nnmeans.
Each nnelectronic nnsignature nncan nnonly nnbe nnreused nnby nnone nnother nnperson nnbeyond nnthe nnoriginator. nnT
nnor nnF? nn- nnANSWER: nn✔ nnFalse. nn
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