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8/16/2019 LIMS SAP Integration
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© 2012 IBM Corporation
Pharma & Life-Sciences Industry trainingLIMS !er!ie"
#o"!anara$ %opa
'shim Cho"dhury
IBM %o(a Business Ser!ices
Sep 2012
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© 2012 IBM Corporation2
'genda
La(oratory )unctions* Process )o" and SystemsLandscape
LIMS and S'P +M o!er!ie"
LIMS & S'P Integration
+M-I,I Interface
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La(oratory )unctions
' (usiness function or (usiness unit that interacts "ith a the (usiness units in the manufacturing organi.ation
' (usiness function or (usiness unit that interacts "ith a the (usiness units in the manufacturing organi.ation
+C La(s monitors and contros the /uaity parameters during
the process as "e after the process
+C La(s monitors and contros the /uaity parameters during
the process as "e after the process
nsures the in(ound* out(ound and support materias are
meeting the /uaity parameters
nsures the in(ound* out(ound and support materias are
meeting the /uaity parameters
+uaity parameters are e!auated (y performing the appropriate
tests and !aries (y type of materiastage
+uaity parameters are e!auated (y performing the appropriate
tests and !aries (y type of materiastage
he re/uests 3reguatory re/uirement too4 are su(mitted to +C
La( to perform tests "ith the representati!e sampe of the
materia5
he re/uests 3reguatory re/uirement too4 are su(mitted to +C
La( to perform tests "ith the representati!e sampe of the
materia5
Pro!ides ser!ices to ma6e informa decisions through scientific data
Pro!ides ser!ices to ma6e informa decisions through scientific data
Qualitycontrol
Warehouse(stores)
Mfg.
Quality Assurance
Purchase
Research &Development (R&D)
Clinical rial!ite( CR" )
#tilities
DM$(CMC)
P vali%ation
P'P%analysis
a'e!tu%y Data
Regulatory
!umissions
usiness$unctions
usiness units
Pro%uction
!upplychain
Distriution
Supports ne" product de!eopment (y identifying the suita(e
method of anaysis and de!eoping the ne" methods for the
respecti!e anaysis i5e5 /uaitati!e* /uantitati!e* I7
Supports ne" product de!eopment (y identifying the suita(e
method of anaysis and de!eoping the ne" methods for the
respecti!e anaysis i5e5 /uaitati!e* /uantitati!e* I7
Identified (ased on the ser!ices pro!ided 8 Micro(ioogy a(*
sta(iity a(* "et chemistry a(* anaytica a(* in process a(*
7&, a( etc9
Identified (ased on the ser!ices pro!ided 8 Micro(ioogy a(*
sta(iity a(* "et chemistry a(* anaytica a(* in process a(*
7&, a( etc9
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La(oratory Process )o"
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La(oratory Systems Landscape
;
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Challenges in Labs
Huge Volume of Sample and data management – Identification, Tracking and Reporting
Loss of employees productivity in preparation and managing Reports and Documents
Difficult in identifying the deviation or variations from Standard perating procedures !S"# and correcting
the same
Difficulties in Information sharing – Redundancy in e$periments
Increasing Regulatory Re%uirements and &ood La'oratory "ractices !&L"#
Desire to Improve "roductivity, efficiency of the rgani(ation
Instruments )omple$ity – Vendors profiles
)hallenges in tracking each event in the life cycle of the sample as e$pected in the Regulatory re%uirements
LIMS
' soft"are system used in a(oratories for the
management of sampes* a(oratory users* instruments*
standards and other a(oratory functions such as
in!oicing* pate management* and "or6fo" automation
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perationa ,ri!ers for LIMS Minimize Compliance Failures – Custom workflows, best practices and process validation checks
Reduce Use of Paper - in the a( processes5
Reduce Human rror - (y automating certain data fieds5
nhance !rackin" # !racin" - (y automated trac6ing !ia (ar coding5
$mprove !rendin" 8 pro!ide /uic6 and efficient trending possi(iities5 Currenty trending is done ony once
a year or "hen needed for the in!estigation of a de!iation such as an ut f Scope 3S4 measurement5
$mprove Plannin" - simper and more efficient panning toos5
%utomate &le !est Creation - >hen a suppier has (een audited the test pan can (e ad$usted5 his
shoud (e registered in the Business Process Contro System 3BPCS4 as master of the customer data* (ut
refected in the LIMS5
'enerate (e) Performance $ndicators - possi(iity to automaticay generate ?ey Performance Indicators
3?PI@s4 such as throughput time5
Measure Costs *etter - getting a (etter !ie" on the a(oratory costs in respect to time needed to perform
a test5
Prioritize &les and !ests More fficientl) - ao"ing for urgent sampes to (e tested first5
*) !*uality )ontrol# "ro+ect -a+or "harmaceutical
Mi6e caims that the company reai.ed a 0 to :0 percent gain in resources as a resut of (eing paperess5 It sa!es time (ecause
empoyees no onger print documents to re!ie"* for eAampe5 'ong the "ay* the team considered the company@s ?PI 36ey
performance indicators4 and measured them 8 Mi6e Stor.* %o(a perations IS 8 %o(a +C Systems Program Manager
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S'P-+M 3+uaity Management4
Been around since the 7 50 ,ays
Initiay offered +uaity 'ssuranceD functions
Strong integration "ith In!entory Management functionaities
nsure strict /uaity contro (y triggering inspection
Seamess integration "ith other ogistics modues namey* MM & >M* PP* S,* PM
ffered the +M-I,I interface "hich "as e!eraged (y LIMS !endors to connect to S'P "iththe LIMS systems
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0000
1111
2222
Fsage ,ecision
7esuts 7ecording
+M in 7ecei!ing Inspection & Production
Inspection Pan
7eports
S'P8+MG Inspection Process )o"
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Process )o" - Panning* 7a" Materia 7eceipt and 'ppro!aProcess
Pan Production
Batches
'ssess current
7a" Materias
Send P for deficient
materias
7ecei!e Materia 3%7H4
,o not issue the stoc6
o pant 8 7estricted stoc6
Maintain Materia info
Module + MM
Send a note to La(
o ta6e sampe for
'naysis
$nspection ot
Issue the materia
o the pant
7est5 - Fnrest5
S3"
7e!ie" the sampe
7e/uest and coect the
sampe
Seect a Chromatography
System 3JPLC4 and
compete the test
as gi!en In the method
7e!ie" and integrate
he test resuts
7e!ie" and 'ppro!e the
est resuts
LI-S –
Perform the tests as
defined in the materia
specification and method
3SLB procedure4
LH
Materia Specifications
Methods for performing
the tests
,MS
C,MS
Send the inspection ot K* materia code*Batch* Pant* Inspection ype detais
to LIMS through interface
Send the '77+'+C dispositiontest statusto S'P
LH
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Process )o" 8 Product Manufacture
L011L012
001
P001
,CS
7ecei!e 7M@s for
Process order
Send the panned
Inspection ot detais
for the process order
to LIMS
7ecei!e the Batch
Manufacturing 7ecord
In MS
Aecute the steps as
%i!en in the BM7*
7ecord the detais
Send the sampe to
La( for anaysis
$n process inspection
ot -!est Re.uest for
/arwin0
'nay.e the sampe
as per the specification
(y foo"ing the method
7e!ie" and 'ppro!e the
7esuts
a6e action on the process
in the ,CS MS system
Mo!e the contents to
)inish %oods Store
Restricted &tock
-'R10
S'P
MS
,MSLIMSLHC,MSSend the resuts (ac6 to
S'P MS system
Coect a sampe for Sta(iity studies and startSta(iity study
'77 3Pass)ai4
Calculate 2ields 3 converted,
fficienc) &%P Process 4rder
2ieldin"5
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+M-I,I Interface
Inspection ,ata Interface in +uaity Management
pen interface for integration (et"een S'P-+Mand Aterna LIMS appication 3aso 6no"n asSu(-System4
Synchronous transfer of inspection ,ata
Buid o!er a group of 7)C function modue
Fses direct Program-to-Program communication
Su(-System a"ays start the communication 8 ,o"noad Inspection Specification from
S'P-+M 8 Fpoad the recorded inspection resut (ac6
to S'P 8 Fpoad the Fsage ,ecision (ac6 to S'P
+M-I,I interface "or6s "ith the inspection ot
he inspection ots get generated in S'P side 8 hrough some materia mo!ement 3pro!ided
the appropriate inspection type is acti!e4 8 Manuay5
nce the inspection ot gets created system "iassign the inspection pan "hich in turn in6 upthe ot to the +,7 system as maintained in theresource
S'P "i copy a those inspection ot that isin6ed to some +M su(system 3LIMS4 in ta(e+I>L
Specia status MSFB 8 Mar6ed for Su(systemDfor those inspection ots
Aterna LIMS system "i ca the ree!ant 7)Csto do"noad the inspection ot from S'P to LIMS3seating in +I>L ta(e4
n successfu do"noad of the Insp5 Lot - statuschanged to SFB 8 ransferred to su(systemD5
!er!ie" >or6ing principes
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+M-I,I 7)Cs
)oo"ing three 7)Cs can (e used for
do"noading inspection ot to the
su(system though the +M-I,I interface5 8 +I7)SH,IHSP7+FI7MHS 8 +I7)SH,IHSP,'')7>L2
8 +I7)SH,7+FI7MHS%, '2
8 +I7)SH,7+FI7MHS%,
'2 internay ca the first t"o 7)Cs
Aterna LIMS system needs to ca any of
the a(o!e 7)Cs to do"noad the
inspection ot from S'P
7esut recording for CharacteristicsG 8 +I7)%)'F7'LFS2
Fsage ,ecisionG 8 +I7)%FS'%,CISIH2
nce the usage decision has (een send(ac6 to S'P from the su(-system* the
inspection ot get cosed and the
communication competed5
,o"noading from S'P Fpoading to S'P
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Stoc6 Posting through +M-I,I Interface
+M-I,I interface S'P can ony accept the F, code5
o compete the stoc6 posting at the time of F,* stoc6 posting proposa can
(e assigned "ith the F, code in configuration
his "i ma6e the stoc6 posting automated at the time of F, code upoad5
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Configuration Settings for +M-I,I
Define the Su'4System 8 Aterna LIMS system is 6no"n as the Su(-System 8 )irst step in configuration is to define the su(-system 3LIMS system4 in S'P5 8 Menu-pathG S'P IM% - +uaity Management - +uaity Inspection -
Su(systems - Process +uaity Inspection Fsing +M-I,I Interface
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,efine the Su(-System 8 Contd55
Seect the option ,efine Su(system Connection for +M-I,I InterfaceD5 Create a ne" su(-system for the eAterna LIMS system
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Master ,ata Settings for +M-I,I
Communication is acti!ated at "or6 centerresource e!e
Su(-system must (e assigned to the "or6 centerresource
he resource is to (e used in the inspection pan 8 operation
Integration SchemeG 8 +M-I,I Su(system - 7esource>or6 Center - peration 7esource in
Inspection Pan
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Success Story 8 Mead Nohnson Hutritiona
MNH has used hermo-)isher LIMS appication 3Sampe Manager4 for a of their samping
& inspection acti!ities in a their sites across the go(e 8 they ca it %LIMS 3%o(a LIMS4
Interface "ith their go(a S'P system 3CC4 has (een (uit using +M-I,I
7P has (een used for the ogistics and in!entory part "hereas LIMS has (een used for
samping and inspection
Custom enhancement done in S'P side for to cater MNH specific (usiness re/uirement
he %LIMS-%S'P com(ination is catering a the ogistics and testing functionaities of MNH
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Success Story 8 Pfi.er
Pfi.er has used S+LO LIMS appication 3from L'B'H'%4 for a of their samping &
inspection acti!ities
Interface "ith their S'P CC system has (een (uit using standard +M-I,I
7P has (een used for the ogistics and in!entory part "hereas LIMS has (een used for
Samping Process* +' Inspection & Fsage ,ecision
he LIMS-S'P com(ination is catering a the ogistics and testing functionaities of Pfi.er
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Success Story 8 i Liy
Liy has used (oth standard +M-I,I as "e as custom interface for there !arious samping
& inspection re/uirements
Interface "ith the %LIMS system 3they ha!e t"o other LIMS 8 ',MIH LIMS & F7 LIMS 4
is (uit o!er +M-I,I
7P has (een used for the ogistics and in!entory part "hereas LIMS has (een used for
samping and inspection
Instead of 7)C ca* S'P-LIMS interface in Liy "or6s o!er I,oc "hich is custom de!eopedon top of the standard +M-I,I
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Success Story 8 N & N
N & N has used LIMS interface "ith S'P-+M modue to transfer the resut recording
information
hey ha!en@t used the standard +M-I,I interface* (ut used a custom (uid Interface
ut(ound InterfaceG Send Inspection detais 3Materia* Batch* IL K4 in the form of a fat fie to
LIMS !ia )P
In(ound InterfaceG 7ecei!ing 7esut recording detais from LIMS !ia Midde"are
3>e(method4
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IssuesConcern of +M-I,I
Buid o!er 7)Cs 8 direct point to point communication Logging functionaity for +M-I,I is not ade/uate
Cannot use standard I,ocs to (uid the interface
,etection of interface error is difficut
Stoc6 posting functionaity is a(sent
Ho integration "ith S'P notification functionaity
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'ppendiA
IBM %o(a Business Ser!ices
Sep 2012
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'dditiona Information on +M-I,I
S'P +M-I,I Interface Set-Fp 8 Configuration and Master ,ata
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nhancement of +M-I,I Interface for Batch riented Manufacturing
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synthetic?eyQR2=211;F2===+= 4
S'P P7L Practitioner Aperience 7ea Life - +M-I,I 8 S+L LIMS IH7)'C
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synthetic?eyQ>0:1E2=R1E;20I 4
Inspection ,ata Interface 3httpGhep5sap5comprintdocucoreprint:<cendatapdf+MI)I,I+MI)I,I5pdf 4
+M-I,I 3httpG"""5sdn5sap5comir$scngoportaprtrootdocsi(raryuuid1e((1<1-0(01-0010-;<aa-
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