LIMS SAP Integration

IBM %o(a Business Ser!ices Sep 2012

Pharma & Life-Sciences Industry training LIMS !er!ie" #o"!anara$ #o"!anara$ %opa  'shim Cho"dhury

 'genda

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La(oratory )unctions* Process )o" and Systems Landscape

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LIMS and S'P +M o!er!ie"

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LIMS & S'P Integration

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+M-I,I Interface

La(oratory )unctions  ' (usiness function or (usiness unit that interacts "ith a the (usiness units in the manufacturing organi.ation Pro!ides ser!ices to ma6e informa decisions through scientific data nsures the in(ound* out(ound and support materias are meeting the /uaity parameters

usiness units Clinical rial Research & Development (R&D) !ite( CR" )

Mfg.

!upply chain

+C La(s monitors and contros the /uaity parameters during the process as "e after the process +uaity parameters are e!auated (y performing the appropriate tests and !aries (y type of materiastage he re/uests 3reguatory re/uirement too4 are su(mitted to +C La( to perform tests "ith the representati!e sampe of the materia5 Supports ne" product de!eopment (y identifying the suita(e method of anaysis and de!eoping the ne" methods for the respecti!e anaysis i5e5 /uaitati!e* /uantitati!e* I7 Identified (ased on the ser!ices pro!ided 8 Micro(ioogy a(* sta(iity a(* "et chemistry a(* anaytica a(* in in process a(* 7&, a( etc9

usiness $unctions Warehouse (stores)

Purchase

Quality control

Distriution

Quality  Assurance

DM$ (CMC)

Pro%uction

#tilities

P a'e P'P%  vali%ation!tu%y Data analysis

Regulatory !umissions

La(oratory Process )o"

La(oratory Systems Landscape

Challenges in Labs Huge Volume of Sample and data management – Identification, Tracking and Reporting Difficult in identifying the deviation or variations from Standard perating procedures !S"# and correcting the same Loss of employees productivity in preparation and managing Reports and Documents

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

LIMS

)hallenges in tracking each event in the life cycle of the sample as e$pected in the Regulatory re%uirements ' soft"are system used in a(oratories for the management of sampes* a(oratory users* instruments* standards and other a(oratory functions such as in!oicing* pate management* and "or6fo" automation

perationa ,ri!ers for LIMS 

Minimize Compliance Failures – Custom workflows, best practices and process validation checks

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Reduce Use of Paper - in the a( processes5

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Reduce Human rror - (y automating certain data fieds5

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nhance !rackin" # !racin" - (y automated trac6ing !ia (ar coding5

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$mprove !rendin" 8 pro!ide /uic6 and efficient trending possi(iities5 Currenty trending is done ony once a year or "hen needed for the in!estigation of a de!iation such as an ut f Scope 3S4 measurement5

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$mprove Plannin" - simper and more efficient panning toos5

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 %utomate &le !est Creation - >hen a suppier has (een audited the test pan can (e ad$usted5 his shoud (e registered in the Business Process Contro System 3BPCS4 as master of the customer data* (ut refected in the LIMS5

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'enerate (e) Performance $ndicators - possi(iity to automaticay generate ?ey Performance Indicators 3?PI@s4 such as throughput time5

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Measure Costs *etter - getting a (etter !ie" on the a(oratory costs in respect to time needed to perform a test5

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Prioritize &les and !ests More fficientl) - ao"ing for urgent sampes to (e tested first5

*) !*uality )ontrol# "ro+ect -a+or "harmaceutical Mi6e caims that the company reai.ed a 0 to :0 percent gain in resources as a resut of (eing paperess5 It sa!es time (ecause empoyees no onger print documents to re!ie"* for eAampe5 '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 

S'P-+M 3+uaity Management4 

Been around since the 7 50 ,ays

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Initiay offered +uaity 'ssuranceD functions

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Strong integration "ith In!entory Management functionaities

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nsure strict /uaity contro (y triggering inspection

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Seamess integration "ith other ogistics modues namey* MM & >M* PP* S,* PM

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ffered the +M-I,I interface "hich "as e!eraged (y LIMS !endors to connect to S'P "ith the LIMS systems

S'P8+MG Inspection Process )o"

/ +M in 7ecei!ing Inspection & Production .

Inspection Pan 1 0 2

7esuts 7ecording Fsage ,ecision 7eports

Process )o" - Panning* 7a" Materia 7eceipt and 'ppro!a Process S3"

Maintain Materia info Module + MM 

Pan Production Batches

 'ssess current 7a" Materias

7ecei!e Materia 3%7H4 Send P for deficient ,o not issue the stoc6 materias o pant 8 7estricted stoc6

Send a note to La( o ta6e sampe for  'naysis $nspection ot 

Send the inspection ot K* materia code*

Issue the materia o the pant 7est5 - Fnrest5

Send the '77+'+C dispositiontest status to S'P

Batch* Pant* Inspection ype detais to LIMS through interface LI-S – LH

7e!ie" the sampe 7e/uest and coect the sampe

Perform the tests as defined in the materia specification and method 3SLB procedure4

Materia Specifications

Methods for performing the tests

C,MS Seect a Chromatography System 3JPLC4 and compete the test as gi!en In the method

7e!ie" and integrate he test resuts

LH

7e!ie" and 'ppro!e the est resuts

Process )o" 8 Product Manufacture 7ecei!e 7M@s for Process order  S'P ,CS 001

Send the panned Inspection ot detais for the process order  to LIMS

P001

7ecei!e the Batch Manufacturing 7ecord In MS

MS L011

Aecute the steps as %i!en in the BM7* 7ecord the detais

Send the resuts (ac6 to

Send the sampe to La( for anaysis $n process inspection ot -!est Re.uest for /arwin0

L012

 'nay.e the sampe as per the specification (y foo"ing the method

7e!ie" and 'ppro!e the 7esuts Coect a sampe for  Sta(iity studies and start Sta(iity study

a6e action on the process in the ,CS  MS system

Mo!e the contents to )inish %oods Store Restricted &tock -'R10

,MSLIMSLHC,MS

S'P  MS system  '77  3Pass)ai4

Calculate 2ields 3 converted, fficienc) &%P Process 4rder   2ieldin"5

+M-I,I Interface !er!ie"

>or6ing principes

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Inspection ,ata Interface in +uaity Management

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+M-I,I interface "or6s "ith the inspection ot

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pen interface for integration (et"een S'P-+M and Aterna LIMS appication 3aso 6no"n as Su(-System4

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Synchronous transfer of inspection ,ata

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 Manuay5

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Buid o!er a group of 7)C function modue

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Fses direct Program-to-Program communication

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Su(-System a"ays start the communication  8 ,o"noad Inspection Specification from S'P-+M  8 Fpoad the recorded inspection resut (ac6 to S'P  8 Fpoad the Fsage ,ecision (ac6 to S'P

nce the inspection ot gets created system "i assign the inspection pan "hich in turn in6 up the ot to the +,7 system as maintained in the resource

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S'P "i copy a those inspection ot that is in6ed to some +M su(system 3LIMS4 in ta(e +I>L

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Specia status MSFB 8 Mar6ed for Su(systemD for those inspection ots

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Aterna LIMS system "i ca the ree!ant 7)Cs to do"noad the inspection ot from S'P to LIMS 3seating in +I>L ta(e4

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n successfu do"noad of the Insp5 Lot - status changed to SFB 8 ransferred to su(systemD5

+M-I,I 7)Cs ,o"noading from S'P 

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)oo"ing three 7)Cs can (e used for do"noading inspection ot to the su(system though the +M-I,I interface5  8 +I7)SH,IHSP7+FI7MHS  8 +I7)SH,IHSP,'')7>L2  8 +I7)SH,7+FI7MHS%,  '2  8 +I7)SH,7+FI7MHS%,  '2 internay ca the first t"o 7)Cs Aterna LIMS system needs to ca any of the a(o!e 7)Cs to do"noad the inspection ot from S'P

Fpoading to S'P 

7esut recording for CharacteristicsG  8 +I7)%)'F7'LFS2

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Fsage ,ecisionG  8 +I7)%FS'%,CISIH2

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nce the usage decision has (een send (ac6 to S'P from the su(-system* the inspection ot get cosed and the communication competed5

Stoc6 Posting through +M-I,I Interface 

+M-I,I interface S'P can ony accept the F, code5

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o compete the stoc6 posting at the time of F,* stoc6 posting proposa can (e assigned "ith the F, code in configuration

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his "i ma6e the stoc6 posting automated at the time of F, code upoad5

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% - +uaity Management - +uaity Inspection - Su(systems - Process +uaity Inspection Fsing +M-I,I Interface

,efine the Su(-System 8 Contd55 

Seect the option ,efine Su(system Connection for +M-I,I InterfaceD5

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Create a ne" su(-system for the eAterna LIMS system

Master ,ata Settings for +M-I,I 

Communication is acti!ated at "or6 centerresource e!e

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Su(-system must (e assigned to the "or6 centerresource

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he resource is to (e used in the inspection pan 8 operation

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Integration SchemeG  8 +M-I,I Su(system - 7esource>or6 Center - peration 7esource in Inspection Pan

Success Story 8 Mead Nohnson Hutritiona 

MNH has used hermo-)isher LIMS appication 3Sampe Manager4 for a of their samping & inspection acti!ities in a their sites across the go(e 8 they ca it %LIMS 3%o(a LIMS4

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Interface "ith their go(a S'P system 3CC4 has (een (uit using +M-I,I

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7P has (een used for the ogistics and in!entory part "hereas LIMS has (een used for samping and inspection

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Custom enhancement done in S'P side for to cater MNH specific (usiness re/uirement

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he %LIMS-%S'P com(ination is catering a the ogistics and testing functionaities of MNH

Success Story 8 Pfi.er  

Pfi.er has used S+LO LIMS appication 3from L'B'H'%4 for a of their samping & inspection acti!ities

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Interface "ith their S'P CC system has (een (uit using standard +M-I,I

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7P has (een used for the ogistics and in!entory part "hereas LIMS has (een used for Samping Process* +' Inspection & Fsage ,ecision

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he LIMS-S'P com(ination is catering a the ogistics and testing functionaities of Pfi.er 

Success Story 8 i Liy 

Liy has used (oth standard +M-I,I as "e as custom interface for there !arious samping & inspection re/uirements

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Interface "ith the %LIMS system 3they ha!e t"o other LIMS 8 ',MIH LIMS & F7 LIMS 4 is (uit o!er +M-I,I

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7P has (een used for the ogistics and in!entory part "hereas LIMS has (een used for samping and inspection

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Instead of 7)C ca* S'P-LIMS interface in Liy "or6s o!er I,oc "hich is custom de!eoped on top of the standard +M-I,I

Success Story 8 N & N 

N & N has used LIMS interface "ith S'P-+M modue to transfer the resut recording information

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hey ha!en@t used the standard +M-I,I interface* (ut used a custom (uid Interface

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ut(ound InterfaceG Send Inspection detais 3Materia* Batch* IL K4 in the form of a fat fi e to LIMS !ia )P

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In(ound InterfaceG 7ecei!ing 7esut recording detais from LIMS !ia Midde"are 3>e(method4

IssuesConcern of +M-I,I 

Buid o!er 7)Cs 8 direct point to point communication

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Logging functionaity for +M-I,I is not ade/uate

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Cannot use standard I,ocs to (uid the interface

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,etection of interface error is difficut

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Stoc6 posting functionaity is a(sent

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Ho integration "ith S'P notification functionaity

IBM %o(a Business Ser!ices Sep 2012

 'ppendiA

 'dditiona Information on +M-I,I 

S'P +M-I,I Interface Set-Fp 8 Configuration and Master ,ata 3 httpsG"5i(m5comser!icespractitionerportappSer!etsdispay,ocument5"ss synthetic?eyQPE202=>::0)11 4

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nhancement of +M-I,I Interface for Batch riented Manufacturing 3 httpsG"5i(m5comser!icespractitionerportappSer!etsdispay,ocument5"ss synthetic?eyQR2=211;F2===+= 4

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S'P P7L Practitioner Aperience  7ea Life - +M-I,I 8 S+L LIMS IH7)'C 3 httpsG"5i(m5comser!icespractitionerportappSer!etsdispay,ocument5"ss synthetic?eyQ>0:1E2=R1E;20I 4

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Inspection ,ata Interface 3httpGhep5sap5comprintdocucoreprint: