IBM Global Business Services

Sep 2012

Pharma & Life-Sciences Industry training

LIMS Overview
Yowvanaraj Gopal
Ashim Chowdhury

© 2012 IBM Corporation

Agenda

 Laboratory Functions, Process Flow and Systems

Landscape
 LIMS and SAP QM overview
 LIMS & SAP Integration
 QM-IDI Interface

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 Laboratory Functions

A business function or business unit that interacts with all the business units in the manufacturing organization

Provides services to make informal decisions through scientific data

Ensures the inbound, outbound and support materials are Business units
meeting the quality parameters Research & Clinical Trial Supply
Mfg.
Development (R&D) Site( CRO ) chain
QC Labs monitors and controls the quality parameters during
the process as well after the process
Business Functions
Quality parameters are evaluated by performing the appropriate Purchase
Warehouse
tests and varies by type of material/stage (stores)

The requests (regulatory requirement too) are submitted to QC Distribution Quality Production
Lab to perform tests with the representative sample of the control
material.

Supports new product development by identifying the suitable Quality

Utilities
Assurance
method of analysis and developing the new methods for the
respective analysis i.e. qualitative, quantitative, IR

Identified based on the services provided – Microbiology lab, DMF TTP Ba/Be Pk/Pd
stability lab, wet chemistry lab, analytical lab, in process lab, (CMC) validation Study Data analysis
R&D lab etc… Regulatory Submissions

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Laboratory Process Flow

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Laboratory Systems Landscape

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 Challenges in Labs

Huge Volume of Sample and data management – Identification, Tracking and Reporting

Difficult in identifying the deviation or variations from Standard Operating procedures (SOP) and correcting
the same

Loss of employees productivity in preparation and managing Reports and Documents

Difficulties in Information sharing – Redundancy in experiments

Increasing Regulatory Requirements and Good Laboratory Practices (GLP)

Desire to Improve Productivity, efficiency of the Organization

Instruments Complexity – Vendors profiles

LIMS
A software system used in laboratories for the
Challenges in tracking each event in the life cycle of the sample as expected in the Regulatory requirements

management of samples, laboratory users, instruments,

standards and other laboratory functions such as
invoicing, plate management, and workflow automation
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 Operational Drivers for LIMS
 Minimize Compliance Failures – Custom workflows, best practices and process validation checks
 Reduce Use of Paper - in the lab processes.
 Reduce Human Error - by automating certain data fields.
 Enhance Tracking & Tracing - by automated tracking via bar coding.
 Improve Trending – provide quick and efficient trending possibilities. Currently trending is done only once a
year or when needed for the investigation of a deviation such as an Out Of Scope (OOS) measurement.
 Improve Planning - simpler and more efficient planning tools.
 Automate Sample Test Creation - When a supplier has been audited the test plan can be adjusted. This
should be registered in the Business Process Control System (BPCS) as master of the customer data, but
reflected in the LIMS.
 Generate Key Performance Indicators - possibility to automatically generate Key Performance Indicators
(KPI’s) such as throughput time.
 Measure Costs Better - getting a better view on the laboratory costs in respect to time needed to perform a
test.
 Prioritize Samples and Tests More Efficiently - allowing for urgent samples to be tested first.

QC (Quality Control) Project: Major Pharmaceutical

Mike claims that the company realized a 30 to 40 percent gain in resources as a result of being paperless. It saves time because
employees no longer print documents to review, for example. Along the way, the team considered the company’s KPI (key
performance indicators) and measured them – Mike Storz, Global Operations IS – Global QC Systems Program Manager

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SAP-QM (Quality Management)
 Been around since the R/3 3.0 Days
 Initially offered “Quality Assurance” functions
 Strong integration with Inventory Management functionalities
 Ensure strict quality control by triggering inspection
 Seamless integration with other logistics modules namely, MM & WM, PP, SD, PM
 Offered the QM-IDI interface which was leveraged by LIMS vendors to connect to SAP with
the LIMS systems

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SAP–QM: Inspection Process Flow

1 QM in Receiving Inspection & Production

2 Inspection Plan

3 Results Recording

4 Usage Decision

5 Reports

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 Process Flow - Planning, Raw Material Receipt and Approval
Process
SAP Maintain Material info
Module - MM

Send a note to Lab

Receive Material (GRN) To take sample for
Plan Production Assess current Send PO for deficient Issue the material
Do not issue the stock Analysis
Batches Raw Materials materials To the plant
To plant – Restricted stock Inspection Lot
Rest. -> Unrest.

Send the inspection lot #, material code,

Send the ARR/QAQC disposition/test status
Batch, Plant, Inspection Type details to SAP
to LIMS through interface

LIMS –

ELN
Perform the tests as
Review the sample defined in the material
Request and collect the specification and method
sample (SLB procedure)
ELN
CDMS
Select a Chromatography
System (HPLC) and Review and integrate Review and Approve the
complete the test The test results Test results
as given In the method

Material Specifications

Methods for performing

the tests

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 Process Flow – Product Manufacture

Receive RM’s for

Process order

SAP
DCS
Send the planned TT001
Inspection lot details PT001
for the process order
to LIMS

Receive the Batch

Manufacturing Record
In MES

MES
LT011
LT012

Execute the steps as

Send the sample to Analyze the sample Move the contents to
Given in the BMR, Review and Approve the Take action on the process Finish Goods Store
Lab for analysis as per the specification
Record the details Results in the DCS / MES system Restricted Stock
In process inspection by following the method
Lot (Test Request for (GRN)
Darwin) Collect a sample for
Stability studies and start
Stability study
Send the results back to
EDMS/LIMS/ELN/CDMS
SAP / MES system Calculate Yields % converted,
Efficiency SAP Process Order
ARR / (Pass/Fail) Yielding.

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QM-IDI Interface
Overview
 Inspection Data Interface in Quality Management
 Open interface for integration between SAP-QM
and External LIMS application (also known as
Sub-System)
 Synchronous transfer of inspection Data
 Build over a group of RFC function module
 Uses direct Program-to-Program communication
 Sub-System always start the communication
– Download Inspection Specification from SAP-
QM
– Upload the recorded inspection result back to
SAP
– Upload the Usage Decision back to SAP
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Working principles
 QM-IDI interface works with the inspection lot
 The inspection lots get generated in SAP side
– Through some material movement (provided
the appropriate inspection type is active)
– Manually.
 Once the inspection lot gets created system will
assign the inspection plan which in turn link up
the lot to the QDR system as maintained in the
resource
 SAP will copy all those inspection lot that is linked
to some QM subsystem (LIMS) in table QIWL
 Special status “MSUB – Marked for Subsystem”
for those inspection lots
 External LIMS system will call the relevant RFCs
to download the inspection lot from SAP to LIMS
(seating in QIWL table)
 On successful download of the Insp. Lot - status
changed to “SUB – Transferred to subsystem”.
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QM-IDI RFCs

Downloading from SAP Uploading to SAP

 Following three RFCs can be used for  Result recording for Characteristics:
downloading inspection lot to the – QIRF_GET_FEATURE_VALUES2
subsystem though the QM-IDI interface.
 Usage Decision:
– QIRF_SEND_INSP_REQUIREMENTS
– QIRF_GET_USAGE_DECISION2
– QIRF_SEND_INSP_DATA_FOR_WL2
– QIRF_SEND_REQUIRMENTS_GET_D  Once the usage decision has been send
AT2 back to SAP from the sub-system, the
– QIRF_SEND_REQUIRMENTS_GET_D inspection lot get closed and the
AT2 internally call the first two RFCs communication completed.
 External LIMS system needs to call any of
the above RFCs to download the
inspection lot from SAP

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Stock Posting through QM-IDI Interface

 QM-IDI interface SAP can only accept the UD code.

 To complete the stock posting at the time of UD, stock posting proposal can
be assigned with the UD code in configuration
 This will make the stock posting automated at the time of UD code upload.

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Configuration Settings for QM-IDI

 Define the Sub-System:

– External LIMS system is known as the Sub-System
– First step in configuration is to define the sub-system (LIMS system) in SAP.
– Menu-path: SAP IMG -> Quality Management -> Quality Inspection ->
Subsystems -> Process Quality Inspection Using QM-IDI Interface

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 Define the Sub-System – Contd..

 Select the option “Define Subsystem Connection for QM-IDI Interface”.

 Create a new sub-system for the external LIMS system

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Master Data Settings for QM-IDI

 Communication is activated at work center/resource level

 Sub-system must be assigned to the work center/resource
 The resource is to be used in the inspection plan – operation
 Integration Scheme:
– QM-IDI Subsystem -> Resource/Work Center -> Operation Resource in
Inspection Plan

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Success Story – Mead Johnson Nutritional
 MJN has used Thermo-Fisher LIMS application (Sample Manager) for all of their sampling
& inspection activities in all their sites across the globe – they call it GLIMS (Global LIMS)
 Interface with their global SAP system (ECC) has been built using QM-IDI
 ERP has been used for the logistics and inventory part whereas LIMS has been used for
sampling and inspection
 Custom enhancement done in SAP side for to cater MJN specific business requirement
 The GLIMS-GSAP combination is catering all the logistics and testing functionalities of MJN

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Success Story – Pfizer
 Pfizer has used SQL* LIMS application (from LABVANTAGE) for all of their sampling &
inspection activities
 Interface with their SAP ECC system has been built using standard QM-IDI
 ERP has been used for the logistics and inventory part whereas LIMS has been used for
Sampling Process, QA Inspection & Usage Decision
 The LIMS-SAP combination is catering all the logistics and testing functionalities of Pfizer

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Success Story – Eli Lilly
 Lilly has used both standard QM-IDI as well as custom interface for there various sampling
& inspection requirements
 Interface with the GLIMS system (they have two other LIMS – ADMIN LIMS & EURO LIMS
) is built over QM-IDI
 ERP has been used for the logistics and inventory part whereas LIMS has been used for
sampling and inspection
 Instead of RFC call, SAP-LIMS interface in Lilly works over IDoc which is custom developed
on top of the standard QM-IDI

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Success Story – J & J
 J & J has used LIMS interface with SAP-QM module to transfer the result recording
information
 They haven’t used the standard QM-IDI interface, but used a custom build Interface
 Outbound Interface: Send Inspection details (Material, Batch, IL #) in the form of a flat file to
LIMS via FTP
 Inbound Interface: Receiving Result recording details from LIMS via Middleware
(Webmethod)

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Issues/Concern of QM-IDI

 Build over RFCs – direct point to point communication

 Logging functionality for QM-IDI is not adequate
 Cannot use standard IDocs to build the interface
 Detection of interface error is difficult
 Stock posting functionality is absent
 No integration with SAP notification functionality

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IBM Global Business Services
Sep 2012

Appendix

© 2012 IBM Corporation

Additional Information on QM-IDI

 SAP QM-IDI Interface Set-Up – Configuration and Master Data (

https://w3.ibm.com/services/practitionerportal/ppServlets/displayDocument.wss?syntheticKey=P920327W4
4803F11 )
 Enhancement of QM-IDI Interface for Batch Oriented Manufacturing (
https://w3.ibm.com/services/practitionerportal/ppServlets/displayDocument.wss?syntheticKey=Z272115U27
877Q87 )
 SAP PE@RL Practitioner Experience @ Real Life - QM-IDI – SQL LIMS INTERFACE (
https://w3.ibm.com/services/practitionerportal/ppServlets/displayDocument.wss?syntheticKey=W041927Z19
520I83 )
 Inspection Data Interface (http://help.sap.com/printdocu/core/print46c/en/data/pdf/QMIFIDI/QMIFIDI.pdf )
 QM-IDI (http://www.sdn.sap.com/irj/scn/go/portal/prtroot/docs/library/uuid/1ebb1361-0b01-0010-56aa-
c780c5446963?QuickLink=index&overridelayout=true&5003637692592 )

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