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MedImmune
PM050 Delivery Work Package Template
Template Version Number: !"
DP" to cover #usti$y
Document Details
Pro%ect Title: BMS PV Integration
Document &tatus 'Version:
DP1 0.1
Pro%ect (e$erence)ode: XXX
)ustomer *usiness+rea:
Patient Safety Pro%ect P,ase: DWP created at DP1for Justify
Primary Pro%ectManager:
Delivery -rganisationPro%ect Manager:
Karthic Suu!aran
Pro%ect &ponsor: Prepared by: "o#ert Sanche$
Date (aised: ./piry Date:
Target &tart Date t,isp,ase1:
1%& '(r&)01% Target )ompletionDate t,is p,ase1:
*0&May&)01%
Document Pre2+pproval
+rea Name 3 (ole +pproval Date
+inancia, -es
o!!ercia, -es
"esources -es
Pro/ect Methodo,ogy -es
Integrated 'ssurance -es
'rchitecture -es
"un -es
Disclaimer
If you are reading a co(y of this docu!ent i.e. (rint out of contro,,ed e,ectronic docu!ent or ane,ectronic co(y of a et in signed (a(er docu!ent2 you !ay #e reading an uncontro,,ed 3ersion.Before !aing u(dates4 (,ease ensure that you are using the ,atest 3ersion.
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Version )ontrol
Version Date Description o$ ),anges +ut,or
1.0 ))&May&)01% Initia, 3ersion :o(i :o3indara/an
1.1 )7&May&)01% ;(dated as (er WP< "itia Jain
(e$erenced Documents
Name Version 4ocation
Data Migration '((roach 1.0
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1. Summary
1.1 Context and Project Summary1.1.1 Summary
'stra>eneca?s ac@uisition of the BMS Dia#etes Portfo,io has resu,ted in the need forincor(orating BMS? Patient safety4 'A data and Source docu!entation for the drugs underconsideration into its eisting 'd3erse A3ent "e(orting Syste! Sa((hire2.
'stra>eneca uses Sa((hire as an 'd3erse A3ent "e(orting Syste! 'A"S2 hich ca(turesc,inica, and (ost !areting ad3erse e3ents. BMS i,, #e using '":;S as their 'd3erse A3ent"e(orting Syste! 'A"S2 syste!. urrent,y BMS is in the (rocess of !igrating fro! theireisting 'A"S syste! '"AS into '":;S.
'":;S V 5.0.*.1 i,, #e used as the BMS :,o#a, Drug Safety Syste! for (rocessingor,dide ad3erse e3ent case re(orts for drugs.
1.1.2 Business Requirements
Che Business ;ser "e@uire!ents S(ecification ha3e #een ca(tured in the fo,,oing eydocu!entE
1. BMS Data Migration Fuestionnaire De3e,o(ed #y ogni$ant ith detai,s on theagreed sco(e for the (ro/ect in discussion ith '> and BMS Staeho,ders
Chis docu!ent for!s the #ase,ine sco(e for the (ro/ect going forard.
GoteE 'ny further changes re@uired i,, need to #e hand,ed #y the for!a, change contro,(rocess to assess i!(act on ti!e4 cost and @ua,ity.
1.1.3 Performance to Date
We are satisfied that the (ro/ect has co!(,eted the necessary de,i3era#,es tothe ,e3e, of detai, that can su((ort this (ro/ect !o3ing forard.
',, riss are u( to date and there are no non !a/or issues at this ti!e.
',though the sco(e of the functiona,ity has increased4 this is not significantand is ithin acce(ta#,e (ara!eters.
H3era,, e are satisfied ith the (erfor!ance of IS I"M fro! an IS PDM(ers(ecti3e hence the :reen "': re(ort.
GREEN
1.2 Delivery Wor Paca!e Summary
Chis is the first de,i3ery or (acage for /ustify (hase.
1.3 "inancial Summary # "orecasted Costs
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+ro! DP* the o3era,, funding re@uired for the (ro/ect o3er a *9 ees (eriod Jun )01% & Jan)01%2 is 666 7&D4 hich inc,udes a 19 contingency. GoteE Chis inc,udes #oth (ro/ect andso!e of the #usiness (rocess outsourcing costs.
'greed #udget fro! DP1 is sti,, 3a,id and the (ro/ect i,, de,i3er ithin the #udget agreed inDP1. Chis is #ased on the actua,s to date and re3ised esti!ates fro! ogni$ant increase ofXXXX ;SD2.
+)TIVIT8 *8 9DD I&
4ine itemPrevious
WorkPackages1
T,is WorkPackage
.stimate o$remaining
ork beyondt,is orkpackage
TotalsActuals to
date
#usti$y 0 0 0 0 $0
Initiate 3 Plan 0 0 0 0 $0
+nalyse 3 Design 0 0 0 0 $0
*uild to )lose 0 0 0 0 $0Total 0 0 0 0 $0
ontingency 0 0 0 0 $0Total Including)ontingency
0 0 0 0 $0
)osts in ot,er areas *P-1 0
Total .stimated Pro%ect cost 0
2. Delivery Wor Paca!e De$nition
2.1 Sco%e
2.1.1 &n Sco%e'
T,erapeutic +reaE Dia#etes
Drug Types :o ,inica,6In3estigationa,o Mareted
;ey *rands under considerationEo Hng,y$a saag,i(tin2o Ko!#ig,y$eL X" saag,i(tin and !etfor!in , etended re,ease2o da(ag,if,o$in !areted as +origa outside the ;S2o Byetta eenatide2o
Bydureon eenatide etended&re,ease for in/ecta#,e sus(ension2o !etre,e(tino Sy!,in (ra!,intide acetate2
)ases TypeEo Transactional casedata current case 3ersion2 E H(en cases sti,, #eing fo,,oed&
u(o
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Identification of !etadata used in 'W'"A '":;S24 !a((ing it toSa((hire and definition ado(tion of a !ethod to u(date it.
Migration of a,, current case data a,, s(ontaneous cases fro! BMS thatare not current,y in '>2 4 su((ressed cases and o,d case ID fro! 'W'"A'rgus2 to Sa((hire
'ddition of ne6additiona, fie,ds !a. of 10 fie,ds2 for ne functiona,itiesthat are current,y not a3ai,a#,e in Sa((hire to acco!!odate the BMS data
o Source Docu!ent transfer to Sa((hire ',, DIMS Source docu!ents into Sa((hire
o Data f,o to SMS
2.1.2 (ut of Sco%e
Periodic re(orts
;(dates to #usiness and re(orting ru,es in Sa((hire
Data !igration fro! 'W'"A to Jas(er is considered out of sco(e for this (ro/ect
Data !igration fro! A!(irica to '> SMS is considered out of sco(e for this (ro/ect
Data !igration fro! 'ris J to ,inica,Wors is considered out of sco(e for this (ro/ect
Data !igration fro! 'W'"A to PSI6SSI is considered out of sco(e for this (ro/ect
Go audit data i,, #e !igrated fro! 'W'"A to S'PPI"A
Migration of (a(er #ased source docu!ents is not in sco(e
'rchi3a, of BMS data and docu!ents is not in sco(e of this (ro/ect
Go change i,, #e done in "'VA and IMP'C interfaces
'ny u(grade of eisting syste!s is considered out of sco(e
'>DD u(grade is considered out of sco(e.
Go additiona, data i,, #e transferred fro! Sa((hire to ,inica,Wors as a resu,t of thetransfer fro! 'W'"A.
2.2 )ssum%tions and *no+n Riss
'ssu!(tions
1. Che 'W'"A 'rgus2 "DM !a((ing doc are a3ai,a#,e (rior to start of Design.). 'W'"A goes ,i3e as (,anned in Se(t )01%.*. Patient safety onso,idation (ro/ect is co!(,eted #efore the !igration of case fro!
BMS%. SMAs fro! '> and BMS shou,d #e a3ai,a#,e for the +ie,d to fie,d !a((ing eercise
and this ou,d #e critica, to the integration.9. Chere cou,d #e %&9 runs to !igration #ased on Medi!!une and A!erson !igrations2N. Che !igration i,, in3o,3e O 1%04000 cases. Che !igration i,, add a#out 19 of cases
to the eisting data#ase 3o,u!e2.
5. Data c,eansing is e(ected to #e !ini!a, and is considered as the difference #eteendata for!ats stored #eteen syste!s. Chis need to #e re3ieed again after theana,ysis of (roduction '":;S data.
7. BMS data#ase su((orts de3ice re(orting. De3ice is for drug de,i3ery on,y and i,,count as ,oest category of !edica, de3ice. Medica, de3ice hand,ing 6 re(orting !ayneed to #e su((orted as an enhance!ent to Sa((hire and Jas(er as e need to hand,efo,,o&u( cases. Geed for de3ice infor!ation to #e ca(tured in sa((hire as e,, as inJas(er.
8. 10 Ge fie,ds ou,d need to #e created in eisting Sa((hire and Jas(er in for fo,,o&u( ases2. 'ny addition to the nu!#er of fie,ds ou,d need to #e re3isited during theana,ysis (hase.
10. I!(act to '>I' A)B con3ersions2 as a resu,t of additiona, (roducts yet to #econsidered. Do they need to #e infor!ed for further configurations if any
11. 'rgus data !ode, i,, #e O88 standard i.e. !ini!a, custo!i$ation2
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1). Data transfor!ations fro! BMS to sa((hire are considered to #e !ini!a, and anychanges this ou,d need to #e re3ieed again after the ana,ysis of (roduction '":;Sdata.
Shou,d these assu!(tions (ro3e incorrect the or !ay #e de,ayed and6or costs !ay increase.
(isk Description -ner
'"AS to 'W'"A data !igration !ust #e co!(,eted #efore'W'"A to Sa((hire data !igration can start
Ka!,esh Shah
Significant changes are needed in Sa((hire functiona,ity "DM4;I4 Worf,o4 etc.2. increasing the ti!e4 cost ris to the (ro/ect 'stra>eneca
Data ,eansing is considered !ini!a, during the esti!ation andany change to this ou,d need to #e re3ieed during the/ustify6ana,ysis (hase
ogni$ant
'3ai,a#i,ity of SMAs fro! BMS during the ana,yse and design(hase
Ka!,esh Shah 6BMS
"egu,atory directi3es affect the (ro/ect ti!esca,es. & Periodicre(orting !ust #e a3ai,a#,e at the 'stra>eneca side. Data!igration !ust #e co!(,eted for (eriodic re(orting to #ea3ai,a#,e
ogni$ant
BMS cannot (ro3ide '":;S etract fi,es in ti!e for ogni$ant'D tea!.
Ka!,esh Shah 6 BMS
'W'"A i!(,e!entation is de,ayed (ast Se(t )01%.Chis ou,dde,ay the start of Sa((hire ;'C as for 3a,idation reasons as they
cou,d on,y #e carried out on (roduction data.
Ka!,esh Shah 6 BMS
Data !igration duration is too ,ong for nor!a, go&,i3e % dayindo.
'stra>eneca 6 ogni$ant
Insufficient headroo! for additiona, BMS cases docu!ents. ogni$ant 6 'stra>eneca
Patient Safety Integration is de,ayed (ast Go3 )01%4 causingsource docs to #e !igrated to S'M.
'stra>eneca
2.3 De%endencies
Che (ro/ect is de(endent on the successfu, de,i3ery of AWARE Migration#y Se( )01% as the(ro/ect can ha3e the etract fro! (roduction on,y after that.
Che (ro/ect is de(endent on the successfu, co!(,etion of thePatient Safety Consolidationproject for the docu!ent !igration a((roach.
Che (ro/ect is de(endent u(on ser3ice !aintenance indo #eing agreed that adheres to the(ro/ect schedu,e to a3oid unnecessary de,ays.
Che (ro/ect is de(endent u(on the Maintenance (ro/ects re@uired for the current syste! #eing!anaged inde(endent,y.
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2., )%%roac-
's the user #ase is re,ati3e,y s!a,, the (ro/ect i,, go ,i3e to a,, users at the sa!e ti!e.
Data Migration
Che a((roach has #een docu!ented in the DP91) Data Migration a((roach docu!ent4 seehigh ,e3e, su!!ary #e,oE
)ase Data to &app,ire Asta#,ish data transfer #eteen BMS and '> o(y BMS data in '> netor for !igration ;(,oad BMS data#ase du!( into te!(orary sche!a Atract4 transfor! and ,oad case data fro! te!(orary
sche!a to Sa((hire transaction DB 3ia AC< as (er defined !a((ing ru,es Va,idate and test data Push data fro! transactiona, to "e(orting data !art using eisting AC< /o# Push data to SMS 'rchi3e data to :o,d re(ository
&ource Documents to &app,ire
Asta#,ish data transfer #eteen BMS and '> o(y BMS data in '> netor for !igration Atract and ,oad BMS source docu!ents to Sa((hire fi,e syste! Va,idate and test 'rchi3e to :o,d re(ository
2. Business Case
Che short #usiness case has #een created and su((,ied #y XXXfor XXXXXand a((ro3ed #yPAS on dd Month ----.
Che fu,, #usiness case is no ready and has #een a((ro3ed #y PAS and PIB.
3. Wor Paca!e Plan
3.1 /i!- 0evel Plan
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3.2 ilestones Wor Products
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D+T.
MI4.&T-N.D.&)(IPTI-N
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PM090 De,i3ery Wor Pacage DP91) Migration a((roach
PM*)8 "is "egister
igh ,e3e, ;I !a((ing
Pro/ect (,an
Asti!ates
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MI4.&T-N.D.&)(IPTI-N
+&&-)I+T.D W-(; P(-D7)T ' D.4IV.(+*4.
)9&Ju,&)01% 'na,ysis
DP91) Migration '((roach
'P*1% Data Ma((ing usto!2
'P*5% on3ersion Ma((ing
IG101 "e@uire!ents Cracea#i,ity Matri
PM1)0 onso,idated Pro/ect Manage!ent P,an
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CA970 Cest P,an
CA97) Cest '((roach
MI4.&T-N.T+(9.T
D+T.
MI4.&T-N.D.&)(IPTI-N
+&&-)I+T.D W-(; P(-D7)T ' D.4IV.(+*4.
15&Hct&)01% Bui,d
CA97N Cest Scri(ts
MI4.&T-N.T+(9.T
D+T.
MI4.&T-N.D.&)(IPTI-N
+&&-)I+T.D W-(; P(-D7)T ' D.4IV.(+*4.
09&Dec&)01% Cest CA988 Cest "e(ort
CA987 Cest ,osure Me!oMI4.&T-N.
T+(9.TD+T.
MI4.&T-N.D.&)(IPTI-N
+&&-)I+T.D W-(; P(-D7)T ' D.4IV.(+*4.
09&+e#&)019 De(,oy!ent I!(,e!entation tas ,ist as (er B'; (rocess
,. )dditional Res%onsiilities
ogni$ant i,, #e res(onsi#,e for the de,i3ery of the so,ution fro! the ana,ysis to theend of Syste! Cest.
ogni$ant i,, #e res(onsi#,e for the data !igration of dia#etes cases and Sourcedocu!ents ith su((ort fro! 'W'"A'":;S2.
ogni$ant i,, #e res(onsi#,e for co(ying the source data in (rogra!!e ,e3e,re(ository and '> i,, #e res(onsi#,e for archi3ing it
IBM i,, #e res(onsi#,e for (ro3iding the Infrastructure re@uired !eeting there@uire!ents.
'> i,, tae o3er a,, case hand,ing acti3ities re,ated to the dia#etes (roducts at the endof !igration
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. "inancial Detail # "orecast cost for t-is Delivery WorPaca!e
.1 "orecast Costs
=-(.)+&T )-&T& =-( T=orecast cost
Total
Interna, resource :DD IS
Interna, resource APD
Interna, resource :,o#a, PatientSafety
Interna, resource BMS Business
Interna, resource BMS It
Aterna, resource ogni$ant
Infrastructure
Total ost ontingency 0 0
Total Including )ost )ontingency
.2 Cost Contin!ency
We ha3e #een ad3ised that the ser3ice introduction costs cou,d increase as the neguidance states that they shou,d #e a((roi!ate,y * of de3e,o(!ent costs fora((,ications that i,, #e de3e,o(ed and !anaged #y ogni$ant.
Cra3e, costs ere not inc,uded as (art of the a((ro3ed #usiness case as e did notha3e this guidance a3ai,a#,e then so e i,, need to use a (ro(ortion of the o3era,,contingency to fund this.
4. "inancial Detail # 5stimated 6otal Cost Summary
4.1 5stimated Costs
0"> 0"5 Total
ardare
Interna, resource :DD ISInterna, resource APD
Interna, resource :,o#a, Patient Safety
Interna, resource BMS Business
Interna, resource BMS ItAterna, resource ogni$ant
Chird Party Hrac,e
Chird Party Infor!atica
Chird Party IBM
Ser3ice Hngoing
Total 0 0 0
ost ontingency 0 0 0
Total: T,is Delivery -rganisation 0 0 0
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Business Process Hutsourcing 0 0 0
Total estimated pro%ect costs 0 0 0
-ngoing ?support@ costs ' bene$its1 0"0 0"" Total
0 0 0Ser3ice Hngoing*4000 (er !onth Q1)2
0 00
Total 0 0 0
4.2 5stimatin! )ssum%tions
"ates assu!(tionsogni$ant #ased on ne 'D rates:DD IS #ased on XXX (er +CAPatient Safety :,o#a, #ased on XXX (er +CA
MedI!!une Patient Safety #ased on XXX (er +CA
+o,,oing the IPHM !ode, 19 contingency has #een added to the costings.
Che esti!ates ha3e #een #ased on (ast e(erience ith the S'PPI"A and Medi!!une(ro/ect.
7. Connected Delivery Wor Paca!es
CONNECTED DELIVERY WORK PACKAGES
Document Version &
Name
Description
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!nstructions appendi#
Document pre-approval relates to the contents of this document being approved prior topresentation at a relevant Governance Board. Details of what is being approved b area aregiven below!
Area Reason for appro%al
"inancial
#ill % commit to spend the $ re&uired to deliver the remainingphases of the pro'ect(
#ill the selected solution) if delivered as planned) meet thedocumented business re&uirements) and thus deliver theappropriate service effect(
Does the full business case include a materiall complete andaccurate financial cost and benefit forecast) including both *hangeand Run costs) with clear budget allocations against future phasesof the pro'ect(
#ill the appropriate funding will be in the right place) at the righttime and in the right currenc to pa for the remaining phases ofthe pro'ect(
+s the proposed accounting treatment of pro'ect spend inaccordance with % ccounting ,olicies(
+s the pro'ect within re&uired % Ris imits(
*ommercial re the third part costs within the business case based on
appropriate commercial arrangements(
Resources
#ill the right +/ pro'ect deliver resources be available at the righttime to deliver the net phase of the pro'ect(
#ill the cost of the +/ pro'ect deliver resources to deliver thepro'ect be as per the business case(
#ill the right /E1 +/ resources be available at the right time todeliver the net2 phase of the pro'ect(
#ill the right /E1 resources be available at the right time to deliverthe net phase of the pro'ect(
,ro'ect3ethodolog
+s the pro'ect within re&uired % Ris imits(
+ntegratedssurance
+s the pro'ect within re&uired % Ris imits(
rchitecture #ill the solution compl with the % +/ target architecture(
Run
#ill the right +/ service resources be available at the right time torun and maintain the solution(
#ill the cost of the +/ service resources re&uired to run andmaintain the solution be as per the business case(
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