migration approach-bms pv integration

8/10/2019 Migration Approach-BMS PV Integration

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BMS PV IntegrationDP512 Migration Approach

Template Version Number: 1!1

Document Details

Pro"ect BMS PV Integration

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$e%erence &o'e

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1! 234Ma(42!1 Initial -ersion $iti+a 0ain

$e%erence' Documents

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Table o% &ontents

1 Scope o% Migration11 6eneral Assumptions12 7ut o% Scope518 Abbre-iations51 &omputer S(stems 9

11 BMS S(stems912 Astraeneca S(stems;

15 Ven'orsA$ Document Migration to SAPP=I$122 Summar(18

25 A>A$ &ase Data Migration into SAPP=I$18251 A>A$ &ase Data Migration Strategies18252 A>A$ &ase Data Migration Vali'ation Strateg(19

29 BMS Source Document Migration to SAM#SAPP=I$19291 BMS Source Document Migration Strateg(19

2; Data migration numbers an' estimates1;2;1 Number o% cases1;2;2 Volume o% 'ata to be migrate'1;

2< I'enti%ie' Migration Tools1A$ A>A$ is 7racle Argus)o%% the shel% pro'uct %or patient sa%et( case han'ling,

The scope o% the Migration is:

&ase 'ata migration %rom A>A$ to Sapphire

Source Document migration %rom DIMS to SAPP=I$

BMS cases %lo* %rom SAPP=I$ to SMS

NF$ testing

Per%ormance testing 'ue to increase' 'ata -olume

1.1 General Assumptions

Functional 7nl( close' cases *ill be migrate' an' BMS *oul' pro-i'e a proo% that all the cases are

alrea'( reporte' Nothing that gets migrate' *oul' trigger a report Sapphire *oul' 'e%ault all the cases to &7SD 7nl( the latest -ersion o% the case *oul' nee' to be migrate' 7nl( nglish language content *ill be migrate' %rom A>A$ No %iel' *ill be a''e' to S2B %ormat

Business *ill a'' rele-ant pages to PSI ItHs not re?uire' to s(nc historic cases to 0ASP$ No 'rug co'es *ill be migrate' %rom BMS to SAPP=I$ Both Sapphire an' A>A$ *ill use the same Me'D$A -ersions The original BMS case IDs must be preser-e' through the migration process to support

%ollo*4ups


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Non4%unctional

Migration is consi'ere' to be a one4o%% acti-it( There is no anticipate' increase in hea' count as to support BMS cases as BMS cases are

alrea'( being han'le' in SAPP=I$ No change *ill be 'one to business rules A *ill o*n all %ollo*4ups post migration BMS *ill in%orm A about the %ollo*4ups recei-e' 'uring migration *in'o* an' A business

*ill ta+e care o% entering the same in SAPP=I$ Inherent 'epen'enc( on PS &onsoli'ation pro"ect *hich *oul' migrate source 'ocuments

%rom SAM to SAPP=I$ &lose 'epen'enc( on &A$S to A>A$ migration pro"ect at BMS en' Vali'ation strateg( nee's to be %urther 'e%ine' Data -ali'ation chec+s i% an( *ill be 'e%ine' b( business prior to the 'ata migration acti-it( SAPP=I$Hs capacit( an' per%ormance nee's to be re-ie*e' as all 'ocuments attache' to

cases in A>A$ *ill be migrate' to SAPP=I$ It is assume' that business *oul' accept the 'ela( in a-ailabilit( o% BMS 'ata in reporting

'atabase incase T "ob to push 'ata %rom transactional to $DM ta+es longer than the

migration *in'o*

1.2 Out of Scope

Data migration %rom A>A$ to 0asper is consi'ere' out o% scope %or this pro"ect

Data migration %rom mpirica to A SMS is consi'ere' out o% scope %or this pro"ect

Data migration %rom Aris 0 to &linical>or+s is consi'ere' out o% scope %or this pro"ect

Data migration %rom A>A$ to PSI#SSI is consi'ere' out o% scope %or this pro"ect

No au'it 'ata *ill be migrate' %rom A>A$ to SAPP=I$

Migration o% paper base' source 'ocuments is not in scope

Archi-al o% BMS 'ata an' 'ocuments is not in scope o% this pro"ect No change *ill be 'one in $AV an' IMPA&T inter%aces

An( upgra'e o% eisting s(stems is consi'ere' out o% scope

ADD upgra'e is consi'ere' out o% scope

No a''itional 'ata *ill be trans%erre' %rom Sapphire to &linical>or+s as a result o% the

trans%er %rom A>A$

1.3 Abbreviations

Term Definition

A A'-erse -ent

A Astraeneca

Astraeneca )A,Patient Sa%et(Toolset

Sapphire. 0asper. SAM. 6S ISS. AMASS. PSI. A Impact)note: this is not an ehausti-e list,


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A DDAstraeneca Drug Dictionar( It is a master 'ata o% all 'rugsagainst *hich cases can be possibl( reporte'

Ttract. oa'. Trans%orm &ommonl( use' in 'ata *arehousing to'enote the etraction an' loa'ing operations

M& Mar+eting &ompan(

Me'D$AMe'ical Dictionar( %or $egulator( Acti-ities The terms o% Me'D$A are use' *hile capturing the case 'etails an' in subse?uentreporting

7S 7perating S(stem

PS Patient Sa%et(

PSI#SSI A Pro'uct Sa%et( In%ormation # Stu'( Speci%ic In%ormation

SAM Sa%et( A'-erse -ent Management S(stem

VB Visual Basic

VDM Virtual Data Mining n-ironment

>D& >orl' class Data &entre

>=7>orl' =ealth 7rgani@ation 4 a GN organi@ation hea' ?uartere' in6ene-a. S*it@erlan'

1.4 Computer Systems

Since this is a migration acti-it(. in this section *e pro-i'e a brie% 'escription about the s(stemsin-ol-e' at BMS an' Astraeneca an' *hich -en'ors are in-ol-e' in these s(stems

1.4.1 BMS Systems

1.4.1.1 CARES

&A$S is the s(stem use' b( BMS to capture )an' report, a'-erse e-ents )As,

Since the &A$S s(stem *ill be 'iscontinue' be%ore the migration into Sapphire. anal(sis o% thiss(stem seems to be irrele-ant

1.4.1.2 AWAREA>A$ is 7racle Argus o%% the shel% pro'uct *hich *ill be use' b( BMS to capture As post themigration %rom &A$S to A>A$ A$6GS uses its un'erl(ing 7racle DB repositor( %or storing'ata

Argus -ersion to be use': ;!817racle -ersion 112!8


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1.4.1.3 DIMS

BMS uses DIMS to manage all global source 'ocuments associate' *ith cases an' As

1.4.1.4 ARIS J

BMS uses A$IS 0 %or 0apan A reporting

1.4.2 Astraeneca Systems

1.4.2.1 Sapp!ireSapphire is the A global sa%et( 'atabase s(stem to capture an' report As It is a custom builtsolution %or Astraeneca b( &ogni@ant Sapphire s(stem has the %ollo*ing main logical grouping:

&ases

Sub"ect

Site

Drug / Dosage

A'-erse -ents

Fun'amental concepts to note:

&ases are the nucleus in Sapphire &ases can ha-e -ersions are reporte' %rom a location

%or a 'rug an' can ha-e a'-erse e-ents associate' *ith them

Sub"ects are humans on *hom the 'rugs are a'ministere' Cases are reported by subject.

Site is where the drug is administered It has broa'l( reporter. site an' countr( in%ormation

Drugs contain in%ormation about %ormulation. 'osage. label. etc

Adverse events are any untoward occurrence on subject due to the administration of a

medical product.It nee' not necessaril( ha-e to ha-e a causal relationship *ith thetreatment This is critical in%ormation that nee's to be capture'. %ollo*e' up an' reporte'

Sapphire has a transactional an' a reporting 'atabase Sapphire has more than a hun're'signi%icant transaction tables besi'es a large number o% master 'ata tables A nightl( T pulls thetransaction 'ata to a separate reporting 'atabase

1.4.2.2 Jasper0asper is a ne* Mar+eting &ompan( tool that *as 'eli-ere' in December 2!1! It is a light*eight

*eb J%ront4en'H to the Sapphire s(stem. allo*ing M&s to enter +e( in%ormation about an A. *hichcan be loa'e' to Sapphire %or T&S central 'ata entr( to then enter %ull case in%ormation It alsoallo*s M&s to -ie* an' transmit reports to local regulator( bo'ies an' In-estigators an' thics&ommitteesNo 'ata *ill be migrate' to 0asper %rom A>A$

1.4.2.3 SAM


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Sa%et( A'-erse -ent Management S(stem )SAM, pro-i'es the abilit( to manage all global source'ocuments relate' to a'-erse e-ents Together *ith Sapphire. SAM %orms an integral part o% thePatient Sa%et( Tool Set o% applications o% Astraeneca SAM is ph(sicall( hoste' in the GS The'ata entr( sites in other places aroun' the *orl' use SAM b( %aing. scanning or b( emails )*ithsource 'ocuments as attachments to the emails,SAM uses Documentum e&ontent Ser-er 95SP2 an' 7racle 1!g $2 The user inter%ace is *rittenin &K Net85 an' hoste' in *eb ser-er 7S 2!!A$

There is an impact on SMS %ee' that goes out o% SAPP=I$ into SMS 'ue to technical limitation o%-olume han'ling capacit(

&urrentl( a %ile is sent %rom SAPP=I$ to SMS e-er( 8! mins *hich contains 1! cases each

There is a ris+ o% congestion in SMS s(stem 'ue to hea-( -olume o% cases being migrate' intoSAPP=I$ as a part o% this migration

There is a nee' to 'o 'etaile' anal(sis on -olume han'ling capacit( o% SMS or a nee' to 'esignalternati-e route o% trans%er in case o% migration

1.4.2." #SI$SSIA Patient Sa%et( In%ormation # Stu'( Speci%ic In%ormation )PSI # SSI, is a *eb4base' storage areathat is create' b( the PS business to con-e( pro'uct an' stu'( speci%ic in%ormation to T&S %or entr(o% cases into Sapphire

A business *ill ma+e rele-ant 'ata in A>A$ %or mar+ete' pro'ucts an' open stu'ies a-ailable inPSI#SSI %or T&S to be able to enter cases in Sapphire %or BMS a%ter 6o4i-e Business *ill a''pages to PSI

1.5 Vendors

&ogni@ant L Sapphire. 0asper an' SAM s(stems

o &ogni@ant supports all 8 s(stems an' ha-e 'e-elope' Sapphire / 0asper

uintiles L A>A$ &ase Data

BMS Source 'ocuments

2 Migration Approac!

This section 'escribes the -arious components o% 'ata migration. starting *ith a high le-el o-er-ie*.an' %ollo*e' b( the approach to 'ata cleansing. 'ata migration. 'rug 'ictionar( co'ing an''ocument migration

2.1 dentified !i"ration Components

The BMS A>A$ s(stem that hol's the structure' case 'ata an' unstructure' case 'ata

)electronic 'ocuments,


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The BMS DIMS s(stem that hol's unstructure' case 'ata )source 'ocuments,

The A Sapphire s(stem that hol's the structure' case 'ata

The A SPAP=I$ s(stem that hol's the unstructure' case 'ata )electronic 'ocuments,

depending on PS consolidation project

2.2 #i"$ %evel Approac$

There are t*o approaches as mentione' belo* The en' to en' migration time an'acceptable 'o*ntime *oul' 'etermine the %inal approach

#!ase%: &ase Data an' 'ocuments are trans%erre' %rom BMS but loa' happens in

t*o stages4>ee+ 1: &ase an' A 'ata %rom A>A$ to SAPP=I$>ee+ 2: Documents migration

Big Bang:&ase Data an' 'ocuments are trans%erre' %rom BMS but loa' happens

in one go4Data an' Documents all together

&efore data mi"ration

o All case -ersions in A>A$ *ill be processe' an' mo-e' out o% the A>A$

>or+%lo* prior to the migration


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o BMS 'ata *ill be copie' into a secure =DD. in %orm o% Database 'ump %ile %or case

'ata an' EM %iles %or source 'ocuments. *hich *oul' be trans%erre' to A locationb( mail or personall(

o Files *ill be copie' to A net*or+ location an' subse?uentl( mo-e to In%ormatica

source %ile 'irector(o Documents inclu'ing meta'ata *ill be copie' %rom =DD to SAPP=I$ 'ocument

Database Nee' to *or+ *ith PS consoli'ation team on thisOOo Integrit( chec+ to be 'one on 'ata arri-al

'ata mi"ration (indo(

o Gploa' BMS 'atabase 'ump in a 'atabase schema at A

o T to rea'. trans%orm an' loa' 'ata into SAPP=I$ 'atabase

o A %ile containing all ol' A>A$ case i's an' the ne* Sapphire i's *ill be create'

%rom the migrate' Sapphire 'atabase to be use' %or source 'ocuments migrationo The trans%erre' 'ocuments *ith meta 'ata *ill be uploa'e' to the SAPP=I$

7racle DFS

o The ne* Sapphire case i' *ill be retrie-e' %rom the %ile create' an' use' %or'ocuments uploa'

o The Sapphire reporting 'atabase is up'ate' using the stan'ar' nightl( T *hich

*oul' be run manuall( a%ter migrationo Data -ali'ation chec+s *ill be 'e%ine' b( the business / applie' at the appropriate

migration steps to ensure no 'ata is lost an' 'ata is migrate' accuratel(

After mi"ration (indo(

o BMS *ill in%orm A Business about the %ollo*4up cases recei-e' 'uring migration

*in'o*o A business *ill a'' those cases into Sapphire

o BMS *ill stop entering case 'ata %or these pro'ucts into A>A$

o Ne* case 'ata %or these pro'ucts *ill be logge' into SAPP=I$

o &op( all source 'ata to programme le-el an'ing area %or archi-al


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2.3 #i"$ %evel )rocess *or+flo(


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2.4 'ata !i"ration ,nvironment Strate"y

2.4.1 En&ironments Definition in A

Secured Network shareto +eep source 'ata

Follo*ing Application. 'atabase an' In%ormatica en-ironments are nee'e':

DevelopmentSandbo!4 Non4-ali'ate'#In%ormal. 'e-elopment o% co'e. unit testing. IS

usage

System "est4 Vali'ate'#Formal. %ull s(stem testing. integration testing. IS usage

Pre#Production$alidation 4 Vali'ate'#Formal. Gser Acceptance Testing. Gser an' oa'

Testing. Same as pro'uction )scale' 'o*n,. both IS / Business usage

Production4 Vali'ate'#Formal. 7perational %or en' Gsers. Business usage

%thers4 Training L Vali'ate'#%ormal. user training. Disaster $eco-er( 4 Vali'ate'#%ormal. %or

Disaster $eco-er(

2.4.2 AWARE Case Data Migration to SA##'IRE (ransactiona)

For Data Migration the %ollo*ing ser-ices#apps *ill be nee'e': Secure' Net*or+ share to +eep source 'atabase 'ump A>A$ cleanse' 'ata )source, in %orm o% 'atabase 'ump 7racle 'atabase schema %or loa'ing BMS source 'atabase 'ump BISS T )In%ormatica T %or trans%ormation, Sapphire Transactional )target,

2.4.3 AWARE Doc*ment Migration to SA##'IRE

For Document Migration the %ollo*ing ser-ices#apps *ill be nee'e': A>A$ source 'ocuments Secure' Net*or+ share to +eep source 'ata Sapphire ID mappe' to BMS ID Gploa' Tool Sapphire 7racle DFS

Follo*ing 'iagram 'epicts the same


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2.4.4 S*mmary

The Data Migration )DM, an' BAG *or+ streams *ill *or+ in separate en-ironments %or the'e-elopment an' in%ormal testing

Formal Testing *ill be carrie' out together %rom S(stem Test $oun' 2 This *ill mean sharing o% the Sapphire %ormal en-ironments &lose collaboration *ill be nee'e' bet*een the *or+ streams to co4or'inate the sharing o%

the en-ironments

2.5 A*A-, Case 'ata !i"ration into SA))#-,

2.".1 AWARE Case Data Migration Strategies

The migration strateg( *ith the possible options is gi-en belo* Please note that man( o% these *illbe re-isite' base' on our learning 'uring the migration process o% 'e-elopment an' s(stem testinstances The table belo* represents our current thin+ing

2.".1.1 +et,or-

Data )cleanse'#un4cleanse', *ill be etracte' %rom BMS net*or+ an' rest e-er(thing *ill 'one inA net*or+

2.".1.2 Data (ransmission met!o%

There are three options here as sho*n belo*:


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Sec*re 'DD

#ros as( setup Securit( an' pri-ac( easil( manage' an' truste'

Cons onger cuto-er perio' pensi-e an' time ta+ing process Di%%icult( in han'ling. managing an' recti%(ing etract issues an' errors

i)es!are Sync

#ros Shorter cuto-er %%icient an' %aster process tract errors can be manage' an' recti%ie' easil(

Cons More e%%orts in setup an' con%iguration Securit( an' pri-ac( nee' to be a''resse'

C)o*% /ase% 0Bo.com

#ros Shorter cuto-er %%icient an' %aster process tract errors can be manage' an' recti%ie' easil( Secure' an' agree' approach

Cons More e%%orts in setup an' con%iguration


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2.".1.3 #reparatory ,or-

De%ine the steps o% loa'4 oa' case 'ata %irst an' then source 'ocuments

Bac+up sapphire DB

&op( BMS 'ata etract to A share' net*or+ &reate a temporar( oracle schema to hol' BMS 'atabase 'ump

The re?uirements %or master 'ata %or entering a case in Sapphire must be *ell establishe'

This is to ensure that the migration o% 'ata %rom A>A$ 'oes not %ail 'ue to the lac+ o%re?uire' master 'ata )ie it must satis%( %oreign +e( re?uirements, else*here

Per%orm integrit( chec+

2.".1.4 Etraction (ransformation an% oa% Case %ata to transactiona) DB

A combine' approach to use T routines an' P#S custom routines *ill be use'

2.".1." A Dr*g Dictionary Co%ing

There is no nee' to populate BMS Drug 'ictionar( co'es 7ption to use Auto4enco'er %or re4co'ingto ADD *ill be consi'ere'

2.".1.5 #op*)ation of reporting DB

There are t*o options *hich nee' to be consi'ere' base' in the abilit( o% eisting T "ob to han'lethe huge -olume an' amount o% time ta+en b( the "ob

ecute the eisting T as an' *hen 'ata migration is complete'#ros6

No a''itional e%%ort nee'e' to 'e-elop an' test

Thoroughl( teste' co'e

Cons6

1!+ cases might ta+e long an' hence 'ata ma( not be a-ailable in $eporting DB

imme'iatel( on start o% business

&reate a ne* high per%orming T#7racle "ob to bul+ loa' 'ata

#ros6

=igh per%orming "ob means %aster an' 'ata *oul' be a-ailable in reporting DB

earlier

Cons6

A''itional e%%ort nee'e' to 'e-elop an' test

=ighl( s+ille' resources nee'e' to per%ormance tune the T

Ma( re?uire a''itional#impro-e' in%rastructure

Ne* co'e means more ris+


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&urrentl(. Sapphire uses BISS T ser-ices to pull 'ata %rom Sapphire transactional 'atabase tothe reporting 'atabase

The eisting T "ob ta+es Q45 hours to push Q15!! cases to reporting DB=ence there is a nee' to anal(@e its capabilit( to push 1! C cases an' estimate the time it *oul're?uire

2.".1.7 Etraction an% )oa% so*rce %oc*ments to Sapp!ire

Nee' to 'e%ine this OO

2.".1.8 Ro))/ac-

$estore DB %rom bac+up

2.".2 AWARE Case Data Migration 9a)i%ation Strategy

The test an' -ali'ation nee' to be 'escribe' in the T5


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The %un'amental or'ering o% tas+ regar'ing 'ata an' 'oc migration is eamine'. since the( areclosel( lin+e'

-ecommendation0 Data migration o% cases must prece'e the 'ocument migration The'ocument etraction can start be%ore case migration because 'ocument are onl( a''e' an'not change'

-ationale0Architectural integrit( must be preser-e' istence o% cases is neccessar(be%ore 'ocuments can come into being

The other strateg( recommen'ations are:

2.5.1.1.2 Etraction of Doc*ments from DIMS

BMS to etract 'ocuments an' trans%er to A -ia agree' transmission metho'

2.5.1.1.3 +et,or- Impact

&urrentl( no impact has been i'enti%ie' on net*or+ as 'ata trans%er is suppose' to happen-ia secure =DD

2.5.1.1.4 Meta%ata Creation

7ption 1: &reate 'ocument relate' meta'ata %rom the source s(stem 'uring the 'ata

migration itsel%

7ption 2: Post migration. create the 'ocument relate' meta'ata %rom Sapphire

-ecommendation0Data migration shoul' co-er the etraction o% i'enti%ie' meta'ata %oreach o% the case that has at least one 'ocument It shoul' be put in an agree' %lat %ile%ormat an' trans%erre' to SAPP=I$

2.5.1.1." ;p)oa% to SA##'IRE %oc*ment management

Nee' to *or+ *ith PS consoli'ation team on it OO

2. 'ata mi"ration numbers and estimates

2.7.1 +*m/er of cases

&urrentl( 1!C cases are i'enti%ie' %or migration

2.7.2 9o)*me of %ata to /e migrate%


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&ase Data: ;5 6BDocuments: 25! 6B

2. dentified !i"ration ools

A tool %or &ogni@ant to import the 'ata %rom 'atabase 'ump to interme'iate staging area

an' into the Sapphire transactional 'atabase For eample. an T tool li+e In%ormaticaPo*er&enter

A tool to import the DIMS eporte' case 'ocuments in bul+ into the A 'ocument repositor(

an' lin+ the 'ocuments *ith the appropriate case )structure' 'ata, in Sapphire

2. ndividual/"roups responsible for mi"ration and verification of identified

components

2.A$ 'ata BMS )le' b( Camlesh,uintiles

Trans%orm / loa' the 'ata into Sapphire -iaan interme'iate staging area

&ogni@ant

2.


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Duration

A A>A$ toSapphire

TBD TBD This inclu'es import o% A>A$%lat %iles. trans%ormation o% 'ata.Sapphire 'atabase bac+ups an'loa' o% 'ata into Sapphire an'the T to the 'atamart

B A>A$ toSAM#SAPP=I$

TBD TBD This inclu'es import o% A>A$unstructure' content )case'ocuments, etracts. SAM'atabase / content repositor(bac+ups an' bul+ import o%unstructure' content etracts intoSAM #SAPP=I$ an' integratingthem *ith cases

2.1=.2 (est to #ro%*ction

&omponent Da(s Time )&T, pecte'

Duration

Notes

A A>A$ toSapphire

TBD TBD This *oul' be a repla( o% theprocess that *as use' to migratethe 'ata into the test )pre4pro',en-ironment. no* using theSapphire pro'uctionen-ironment

B A>A$ toSAM#SAPP=I$

TBD TBD This *oul' be a repla( o% theprocess that *as use' to migratethe 'ata into the test )pre4pro',en-ironment. no* using theSAM#SAPP=I$ pro'uctionen-ironment

2.11 Cutover )lan

7ne o% the %ollo*ing three approaches can be use' to 'e%ine cuto-er plan


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Imme'iate cuto-er

As soon as A is li-e. BMS stops entering cases %or these pro'uctsSapphire is use' to enter all ne* an' a %ollo*4up case %rom the moment s(stem is bac+

Pros:o* cost7perational ease

&ons:=igh ris+

Phase' cuto-er

&ases relate' to 142 'rugs are entere' in Sapphire post %irst phase migration BMScontinues to recei-e cases relate' to other 'rugs till %inal phase migration happens

Sapphire is use' to enter all cases a%ter secon' phase migration

Pros:Me'ium ris+Better user con%i'ence

&ons:More cost7perational compleit(


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-ecommendation0

Phase' cuto-er is recommen'e' to optimi@e ris+ an' cost

2.12 !i"ration resource contact points

For more in%ormation or ans*ers to ?uestion about the ADM migration approach please contact the%ollo*ing people:

2.12.1 So)*tions Arc!itect6

o Name: $iti+a 0ain

o Phone: ;;9323!!1