PM050 DeliveryWork Package Justify BMS PV Integration

8/10/2019 PM050 DeliveryWork Package Justify BMS PV Integration

1/12

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.

05607608 PM090 De,i3ery Wor Pacage Page 1 of 1)


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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


3/12

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



6/12

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

MI4.&T-N.T+(9.T

D+T.

MI4.&T-N.D.&)(IPTI-N

+&&-)I+T.D W-(; P(-D7)T ' D.4IV.(+*4.

*0&May&)01% Justify Phase co!(,ete

PM090 De,i3ery Wor Pacage DP91) Migration a((roach

PM*)8 "is "egister

igh ,e3e, ;I !a((ing

Pro/ect (,an

Asti!ates

MI4.&T-N.T+(9.T

D+T.


+&&-)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

P


9/12

CA970 Cest P,an

CA97) Cest '((roach

MI4.&T-N.T+(9.T

D+T.


+&&-)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.


+&&-)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.


+&&-)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



11/12

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


+ntegratedssurance


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(