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
La(oratory )unctions* Process )o" and Systems Landscape
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 Pro!ides ser!ices to ma6e informa decisions through scientific data nsures the in(ound* out(ound and support materias are meeting the /uaity parameters
usiness units Clinical rial Research & Development (R&D) !ite( CR" )
Mfg.
!upply chain
+C La(s monitors and contros the /uaity parameters during the process as "e after the process +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 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 in process a(* 7&, a( etc9
usiness $unctions Warehouse (stores)
Purchase
Quality control
Distriution
Quality Assurance
DM$ (CMC)
Pro%uction
#tilities
P a'e P'P% vali%ation!tu%y Data analysis
Regulatory !umissions
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 sampes* a(oratory users* instruments* standards and other a(oratory functions such as in!oicing* pate management* and "or6fo" automation
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
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 "ith the LIMS systems
S'P8+MG Inspection Process )o"
/ +M in 7ecei!ing Inspection & Production .
Inspection Pan 1 0 2
7esuts 7ecording Fsage ,ecision 7eports
Process )o" - Panning* 7a" Materia 7eceipt and 'ppro!a Process S3"
Maintain Materia info Module + MM
Pan Production Batches
'ssess current 7a" Materias
7ecei!e Materia 3%7H4 Send P for deficient ,o not issue the stoc6 materias o pant 8 7estricted stoc6
Send a note to La( o ta6e sampe for 'naysis $nspection ot
Send the inspection ot K* materia code*
Issue the materia o the pant 7est5 - Fnrest5
Send the '77+'+C dispositiontest status to S'P
Batch* Pant* Inspection ype detais to LIMS through interface LI-S – LH
7e!ie" the sampe 7e/uest and coect the sampe
Perform the tests as defined in the materia specification and method 3SLB procedure4
Materia Specifications
Methods for performing the tests
C,MS Seect a Chromatography System 3JPLC4 and compete the test as gi!en In the method
7e!ie" and integrate he test resuts
LH
7e!ie" and 'ppro!e the est resuts
Process )o" 8 Product Manufacture 7ecei!e 7M@s for Process order S'P ,CS 001
Send the panned Inspection ot detais for the process order to LIMS
P001
7ecei!e the Batch Manufacturing 7ecord In MS
MS L011
Aecute the steps as %i!en in the BM7* 7ecord the detais
Send the resuts (ac6 to
Send the sampe to La( for anaysis $n process inspection ot -!est Re.uest for /arwin0
L012
'nay.e the sampe as per the specification (y foo"ing the method
7e!ie" and 'ppro!e the 7esuts Coect a sampe for Sta(iity studies and start Sta(iity study
a6e action on the process in the ,CS MS system
Mo!e the contents to )inish %oods Store Restricted &tock -'R10
,MSLIMSLHC,MS
S'P MS system '77 3Pass)ai4
Calculate 2ields 3 converted, fficienc) &%P Process 4rder 2ieldin"5
+M-I,I Interface !er!ie"
>or6ing principes
Inspection ,ata Interface in +uaity Management
+M-I,I interface "or6s "ith the inspection ot
pen interface for integration (et"een S'P-+M and Aterna LIMS appication 3aso 6no"n as Su(-System4
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 Manuay5
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
nce the inspection ot gets created system "i assign the inspection pan "hich in turn in6 up the ot to the +,7 system as maintained in the resource
S'P "i copy a those inspection ot that is in6ed to some +M su(system 3LIMS4 in ta(e +I>L
Specia status MSFB 8 Mar6ed for Su(systemD for those inspection ots
Aterna LIMS system "i ca the ree!ant 7)Cs to do"noad the inspection ot from S'P to LIMS 3seating in +I>L ta(e4
n successfu do"noad of the Insp5 Lot - status changed to SFB 8 ransferred to su(systemD5
+M-I,I 7)Cs ,o"noading from S'P
)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
Fpoading to 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
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
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
,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
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
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
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!eoped on 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 fi e 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
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(m5comser!icespractitionerportappSer!etsdispay,ocument5"ss synthetic?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:
+M-I,I 3httpG"""5sdn5sap5comir$scngoportaprtrootdocsi(raryuuid1e((1<1-0(01-0010-;
