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High Level Risk Assessment (HLRA) for XXX system Document No: HLRA-XXXX-00-R0

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Drft !o"y

High Level Risk Assessment (HLRA)

#or XXXX System

Do$%ment &o' HLRAXXXX**R*

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A""rovl ,ge

&me Designtion De"rtment Sign n- Dte

,re"re- .y

Revie/e- .y

A""rove- .y

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Table of Contents

Purpose.......................................................................................................................................................4

Scope..........................................................................................................................................................4

References..................................................................................................................................................4

Sstem !"er"#e$.......................................................................................................................................4

%&P Re'e"ance...........................................................................................................................................(

References..................................................................................................................................................)

Le"e' of R#s*..............................................................................................................................................+

%A,P ategor#at#on................................................................................................................................/

Summar....................................................................................................................................................

omments:.................................................................................................................................................

Re"#s#on H#stor........................................................................................................................................

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0 ,%r"ose

#s ocument #s prepare to assess te %&P #mpact %A,P categor#at#on an r#s* 'e"e' of tesstem.

1 S$o"e

#s ocument #s app'#ca5'e to XXXX sstem #nsta''e at XXXX 'ocat#on #n 6S7 Lt.

2 Referen$es

a. %A,P-(: A R#s*-8ase Approac to omp'#ant %&P omputer#e Sstems

5. Stanar !perat#ng Proceure for 7a'#at#on of omputer#e Sstem:

3 System +vervie/

9r#te sstem escr#pt#on current proceure $#c sa'' 5e rep'ace 5 sstem $eterapp'#cat#on #s custom#e or stanar soft$are use of te sstem process f'o$ etc..;

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4 56, Relevn$e

No

(.1 ?s te sstem #n"o'"e #n te en"#ronmenta' contro' processes of

fac#'#t#es use for an#ma's #n %LP stu#es or for te manufacture

process#ng pac*ag#ng o'#ng or #str#5ut#on of proucts@

(.2 ?s te sstem use #n te co''ect#on ana's#s or storage of ata from per-

c'#n#ca' stu#es or c'#n#ca' tr#a's@(.3 ?s te sstem use to prouce or process ata tat $#'' 5e use #n 9rug;

regu'ator su5m#ss#ons@

(.4 ?s te sstem use for #str#5ut#on or co''ect#on of #nformat#on #n te

e"ent of a commerc#a' prouct reca'' or #n pat#ent fo''o$-up of pre-

c'#n#ca' or c'#n#ca' tr#a's@

(.( Does te sstem pro"#e #nformat#on tat #s use as e"#ence of

comp'#ance $#t a process '#a5'e to e&terna' au#t or #nspect#on 5

ea't autor#t suc as DA B,BA H! ,HRA or an oter

ea't autor#t@

(.) ?s te sstem use #n te co''ect#on process#ng ana's#s or storage of

ata re'ate to prouct Cua'#t an pat#ent safet@

(.+ ?s te sstem off#c#a'' a"a#'a5'e for te au#t@

(./ ?s te sstem use #n te manufacture or contro' of proucts@

(. ?s te sstem use to contro' Pac*ag#ng or La5e'#ng act#"#t#es@

(.10 ?s te sstem use to ma#nta#n purcas#ng #n"entor or #str#5ut#on ata

for te prouct@

?f one of te Cuest#ons #s ans$ere $#t =esE te Sstem #s c'ass#f#e as %&P re'e"antE an

omputer Sstem 7a'#at#on #s reCu#re.

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7 ERES

App'#ca5'e #f te sstem #s c'ass#f#e as %&P Re'e"antE

No>

NA

).1 Does te sstem support 5us#ness processes tat are part of te prouct

e"e'opment reg#strat#on manufactur#ng or te #str#5ut#on of proucts

tat are to 5e e'#"ere to te 6S an>or Buropean mar*et an>or to anoter mar*et tat #s regu'ate regar#ng BRBS@

?f ).1 Cuest#on #s ans$ere as =esE ten go to te ne&t Cuest#ons.

No> NA

).2 Does te sstem create mo#f ma#nta#n arc#"e retr#e"e or transm#t

e'ectron#c recors spec#f#ca'' reCu#re 5 an %&P regu'at#on@

).3 ?f te sstem processes e'ectron#c recors as note a5o"e are tese

recors use #n te#r e'ectron#c form to support %&P ec#s#ons@

).4 Does te sstem support app'#cat#on of e'ectron#c s#gnatures to recors

tat are reCu#re to 5e s#gne@

?f ).2 an>or ).3 #s ans$ere $#t =esE B'ectron#c recorsE are app'#e to te sstem.

?f ).4 #s ans$ere $#t =esE B'ectron#c s#gnaturesE #s app'#e to te sstem.

Hi h L l Ri k A t (HLRA) f XXX t D N HLRA XXXX 00 R0

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8 Level of Risk

or %&P re'e"ant sstem eterm#ne te FLe"e' of R#s*G 9Se"er#t of arm; 5ase on sstem

#mpact on %&P re'e"ance 8us#ness re'e"ance an fa#'ure conseCuence. 6se 5e'o$ ta5'e for t#s

purpose.

Assessment Step:Assessment regar#ng %&P re'e"ance 9=es>No;

Assessment regar#ng 8us#ness re'e"ance 9=es>No;

Assessment regar#ng a#'ure onseCuence 9H#g> ,oerate> Lo$> No;

?f sstem #s c'ass#f#e as %&P re'e"ance sstem must 5e automat#ca'' c'ass#f#e as 5us#ness

re'e"ance an at 'east moerate for te fa#'ure conseCuence. ?f sstem #s #mpact#ng on 5us#ness $#c means on act#"#t#es '#*e Cua'#t contro' prouct#on

sa'es etc. ten sstem sou' 5e c'ass#f#e as 8us#ness Re'e"ance.

?f sstem #s c'ass#f#e as ne#ter %&P nor 5us#ness re'e"ant te c'ass#f#cat#on of te fa#'ure

conseCuence cou' not e&cee 'o$.

?f fa#'ure of sstem funct#ona'#t causes a "#o'at#on of %&P regu'at#on $#t #rect #mpact on

Prouct Cua'#t Pat#ent Safet an Data ?ntegr#t ten te sstem fa#'ure conseCuences sa''

5e H#g.

?f fa#'ure of sstem funct#ona'#t causes "#o'at#on of %&P regu'at#on $#t No #rect #mpact on

Prouct Cua'#t Pat#ent Safet an Data ?ntegr#t ten te sstem fa#'ure conseCuences sa'' 5e ,oerate.

?f fa#'ure of sstem funct#ona'#t causes an #n#rect "#o'at#on of %&P regu'at#on $#t No #rect

#mpact on Prouct Cua'#t Pat#ent Safet an Data ?ntegr#t ten sstem fa#'ure conseCuences

sa'' 5e Lo$.

?f fa#'ure of sstem funct#ona'#t causes no #mpact on %&P regu'at#on $#t no #rect> #n#rect#mpact on Prouct Cua'#t Pat#ent Safet an Data ?ntegr#t ten sstem fa#'ure conseCuences

sa'' 5e No.

=es- 10 No- 00 H#g- 20 ,oerate- 0/ Lo$- 02

High Le el Risk Assessment (HLRA) for XXX s stem D t N HLRA XXXX 00 R0

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56, Relevn$e .%sinessRelevn$e

#il%re!onse9%en$e

!l%$%lte-Risk

Level of Risk

=es =es H#g 40

H#g No =es H# 30

=es =es ,oerate 2/

No =es ,oerate 1/,oerate No =es Lo$ 12

No =es No 10

No No Lo$ 02Lo$

No No No 00

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mou'es@ 9?f No go for te ne&t Cuest#on;

( ?s sstem custom 5u#'t soft$are or a custom e&tens#on to an est#ng

sstem@

< S%mmry

Respon to te Cuest#ons accor#ng to sect#on ( to / of t#s ocument.

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Re"#s#on No. Date of Re"#s#on Reason for Re"#s#on

R0 Ne$ Document

HLRA

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