LIMS SAP Integration

8/16/2019 LIMS SAP Integration

http://slidepdf.com/reader/full/lims-sap-integration 1/24

© 2012 IBM Corporation

Pharma & Life-Sciences Industry trainingLIMS !er!ie"

#o"!anara$ %opa

'shim Cho"dhury

IBM %o(a Business Ser!ices

Sep 2012



© 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




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



© 2012 IBM Corporation:

La(oratory Process )o"



© 2012 IBM Corporation;

La(oratory Systems Landscape

;



© 2012 IBM Corporation<

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


http://slidepdf.com/reader/full/lims-sap-integration 7/24© 2012 IBM Corporation=

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 &ample !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 &amples 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


http://slidepdf.com/reader/full/lims-sap-integration 8/24© 2012 IBM Corporation

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


http://slidepdf.com/reader/full/lims-sap-integration 9/24© 2012 IBM CorporationE

....

////

0000

1111

2222

Fsage ,ecision

7esuts 7ecording

+M in 7ecei!ing Inspection & Production

Inspection Pan

7eports

S'P8+MG Inspection Process )o"


http://slidepdf.com/reader/full/lims-sap-integration 10/24© 2012 IBM Corporation10

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


http://slidepdf.com/reader/full/lims-sap-integration 11/24© 2012 IBM Corporation11

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




+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




+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



© 2012 IBM Corporation1:

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



© 2012 IBM Corporation1;

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



© 2012 IBM Corporation1<

,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



© 2012 IBM Corporation1=

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




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



© 2012 IBM Corporation1E

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


Samping Process* +' Inspection & Fsage ,ecision

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




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


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




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




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




'ppendiA

IBM %o(a Business Ser!ices

Sep 2012



© 2012 IBM Corporation2:

'dditiona Information on +M-I,I

S'P +M-I,I Interface Set-Fp 8 Configuration and Master ,ata

3 httpsG"5i(m5comser!icespractitionerportappSer!etsdispay,ocument5"sssynthetic?eyQPE202=>::0)11 4

nhancement of +M-I,I Interface for Batch riented Manufacturing

3 httpsG"5i(m5comser!icespractitionerportappSer!etsdispay,ocument5"ss

synthetic?eyQR2=211;F2===+= 4

S'P P7L Practitioner Aperience 7ea Life - +M-I,I 8 S+L LIMS IH7)'C

3 httpsG"5i(m5comser!icespractitionerportappSer!etsdispay,ocument5"ss

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-

c=0c;::<E<+uic6Lin6QindeA&o!errideayoutQtrue&;00<=<E2;E2 4

Date post:	05-Jul-2018
Category:	Documents
Upload:	basusap
View:	294 times
Download:	5 times