Nuances in ERP

(SAP)
integration with LIMS
1. 3
2. Area of Interfacing 3
2.1. SAP QM and LIMS: 3
2.2. SAP MM and LIMS: 4
3. Different mechanism for Interfacing 5
3.1. SAP NetWeaver Process Integration for Enterprise Application Integration 6
3.2 Options within LIMS 7
4. Interface from Regulatory angle 7
5. Conclusion 8
6. Reference: 9
7. About the author 10
Abstract
TABLE OF CONTENTS
1. Abstract
Enterprise Resource Planning systems (the next level above
Manufacturing Resource Planning (MRP) systems that automate
production planning systems) enable cross-functional integration
so that an organization can evolve to a networked manufacturing
company that utilizes real-time monitoring of business functions.
The incorporation of product quality information from the
laboratory within ERP systems is a clear priority for addressing
product release or quarantine / Reprocessing in timely manner as
appropriately necessitated by FDA thru PAT requirements.
Between the production plant and the laboratory that is analyzing
data from production, there is a need for regular exchange of
information about quality and analysis values. In order to leverage
the full benefits of modern ERP solutions, organizations require
automated access to all aspects of their business, including the
process laboratory. This paper is intended to highlight how best
LIMS can be integrated with SAP and what are the areas to be
considered during operational part of it.
2. Area of Interfacing
Depending on nature of laboratory and SAP, LIMS can connect
through various modules. After detailed analysis, it has been found
that the following modules in SAP needs data from LIMS or send
information to LIMS.
SAP QM module in principle works to create Inspection Plan
against a single product or a group of products. Based on sampling
plan information associated with inspection plan, samples are
required to be registered in LIMS. This set of information is now
downloaded to LIMS, to create appropriate number of samples. In
pharmaceutical industry one major challenge is to address the
requirement of specification of a product or a product family. In
most of the cases, specification is defined at LIMS level. However,
in this case, proper attention is to be given to ensure material code is
kept in sync between SAP and LIMS. This section is discussed in
the next section.
Once testing is over of Samples at LIMS, results are required to be
uploaded to SAP either in batch mode or in synchronous mode.
2.1.SAP QM and LIMS
3
4
This uploaded result will also contain Sample quality status. This
information will help SAP to take appropriate Usage Decision. In
addition to this, SAP also needs Samples Testing Results against a
Batch/Lot during generation of Certificate of Analysis. This
information is pulled from LIMS as and when they are needed.
2.2.SAP MM and LIMS
LIMS maintains a smaller version of inventory related to various lab
chemicals and glassware. When quantity of these items falls below a
certain level, it is required to purchase them.
In an organization, where purchases of materials are controlled by
SAP, it is required that LIMS should upload purchase requisition
information to SAP and once the materials are procured, it is to be
updated at LIMS through Goods Receipt Note (GRN). Figure 2
illustrates conventional touch points with respect to connecting
SAP MM module with LIMS.
In case of raw materials and finished products, SAP maintains the
record of the same. Through this interface, SAP usually downloads
that information to LIMS and keep both LIMS and SAP in sync.
Fig: 1 SAP QM Module Functionalities with schematic view of SAP QM and
LIMS interface
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Additional consideration for Material Management interface is in
approval of materials during material inward and after
manufacturing, where after approval stock updation to approved
stocks in MM is done by Quality and this internally leads to FI
integration for release of vendor payments and release of material
for dispensing to production through Production Planning Plant
Information modules.
The entire approval cycle from the moment inspection lot
generation in SAP till COA generation is maintained in LIMS for
audit purposes of FDA including appropriate instrument interfaces
that assist in collecting raw data from instruments pertaining for
specific testing of materials.
New Material Created in SAP
Update Material
PR Created in SAP for That Indent
Generate PO
Receive GRN
Create LOT
Usage Decision Stored in SAP
Issue Material to Cost Centre
Material Created in LIMS
Material Information Transferred to LIMS
Material Information Updated in LIMS
Material Information Transferred to LIMS
Raise Indent
Indent Information Transferred to SAP
Store PR and Indent Mapping in LIMS
PO information Stored in
LIMS for That Indent
PR and Indent Mapping Information Transferred to
LIMS
PO Information Transferred to LIMS
LOT Information Transferred to LIMS
Create Sample for That LOT
Sample Testing Cycle
Usage Decision Information Transferred to SAP
Material Stock Updated in LIMS
SAP LIMS
3.Different mechanism for Interfacing
In order to understand mechanism to interface SAP and LIMS, we
need to have a close look at various interfacing options available in
these two systems. First we will understand, options available within
SAP, following which we will understand about LIMS.
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3.1. SAP NetWeaver Process Integration
for Enterprise Application Integration
SAP NetWeaver Process Integration (PI; formerly known as
Exchange Infrastructure) is a world-class EAI Middleware with
which complex integration requirements between disparate IT
systems can be achieved. A heterogeneous IT environment of a
large enterprise may include mainframe systems like IBM CICS or
AS400, Relational and Hierarchical databases, ERP systems like
SAP or Siebel, Internet Applications based on J2EE/.NET/CGI-
Perl etc, various flavors of Unix/Windows/Macintosh operating
systems and so on. For large companies, the IT infrastructure
continues to grow over many years, spanning over many functional
areas and embrace various technologies, which results in an
extremely complicated IT landscape. Moreover, the individual
systems inside the landscape have dependency between themselves
to accomplish the broader goal of the company. In such cases,
islands of individual systems that are built on different
programming language, transport or network protocols and OS
instruction set need to talk to each other for exchange of business
critical information. Setting up reliable communication channels
between each pair of individual systems can be an even bigger
hurdle, and may quickly become unmanageable. SAP NetWeaver
Process Integration can offer a lot of help in such situations and can
establish an organization-wide, easily manageable, standard
practice of heterogeneous application integration.
Support for the most up-to-date Web Services standards is inbuilt
inside NetWeaver PI 7.1 & 7.0. The latest version of SAP ERP Core
Component, version 6.0, is also fully compliant to Web Services and
SOA standards. Hence, it has become technologically easier for
non-SAP systems to be integrated with SAP ERP. Apart from Web
Services support, NetWeaver PI is shipped with many built-in
adapters which such as: accessing file systems on different
operating systems, accessing databases from various vendors,
accessing mail servers, talking to distributed object-oriented
technologies like DCOM and EJB. For legacy systems which do not
yet support Web Services, these technology specific adapters can be
configured to achieve integration. In case appropriate adapters are
not available in the IT market, custom adapter modules can be
created and deployed on NetWeaver PI server.
For older versions of SAP R/3, (up to version 4.6) support for Web
Services was not available. In such cases, non-SAP systems can
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setup communication channels to SAP R/3 by using the SAP RFC
adapters of NetWeaver PI. RFC(s) are blocks of business logic
written in ABAP programming language, inside SAP ERP system.
These subroutines are configured for remote access from external
systems. In such cases, the non-SAP system, such as a Microsoft
.NET system will speak to NetWeaver PI through .NET adapter or
SOAP, and NetWeaver PI will maintain connectivity to SAP ERP
through RFC adapters. Thus, NetWeaver XI will bridge the gap
between SAP and non-SAP worlds.
Further, if messages flowing between SAP ERP and non-SAP
systems require any processing or manipulation before it is
delivered on to the systems in conversation, custom filters and
intercepting modules can be developed and plugged into
NetWeaver PI. The intercepting modules can perform additional
business logic and data conversion on the data being transferred
from SAP to non-SAP systems (or vice-versa). Such custom filters
can be developed using Java or ABAP. Ang1r@Devi
Various LIMS products use different techniques to connect to
external systems. It depends on architecture and development
platform used by the LIMS Vendors. However, as a general trend, it
has been found LIMS Software is using Web Service (SOAP based
communication protocol) mechanism for connectivity. This option
is lighter in nature and also synchronous. On the other side, some
LIMS products still use file transfer mechanism for interfacing.
Nature of the file may be flat file or XML. But this practice is slowly
going out as file transfer is not only asynchronous but also against
regulatory guideline.
4.Interface from Regulatory angle
In the background of the interface design and implementation is its
validation. To be successful, consider the regulations first; U.S.
GMP regulation 21 CFR 211.63 specifies adequate size and
intended use, 211.68 requires that inputs and outputs be checked
and European Union GMP Annex 11 states that the extent of
validation depends on the use of the system and if novel elements
are incorporated.
Therefore, we need to document in a specification how the
interface will be used. If custom code is used to build the interface,
then further specifications will need to be written concerning the
3.2.Options within LIMS
8
design of the modules of code for handling the data and how errors
will be handled. If files (text files or XML files) are to be transferred
between the systems, the means of ensuring data integrity also will
need to be specified. Requirements must be written so that they can
be either tested or verified and also uniquely numbered so that they
are traceable to the testing. In case direct database connectivity is
used, then proper documentation is needed to establish integrity of
data. Even in case of interfacing using Application Programming
Interfaces, there must be a detailed documentation available
highlighting how the data security and integrity is ensured.
Testing is always based on the documented requirements and
should be designed to show the interface works, as well as how it
handles anticipated problems such as unavailability of the network.
In this case, are data lost or, when the network connection is
restored, are the data resent? The testing from the user's perspective
will be black box, as the design of the interface will not be known. If
a standard interface package is used, the level of testing will be less
than a custom-built interface application. Using a file to transfer the
data between the two applications may require testing to check that
the data cannot be changed and that the integrity remains intact
during the transfer. Adequate size should be tested based on criteria
such as the largest number of samples to be transferred and/or the
number of tests to be performed per sample. The testing will
typically start and end in the LIMS as this is the master for the whole
process.
5.Conclusion
In order to remain competitive, companies need to be able to deliver
consistent product and service quality worldwide. They must be in a
position to guarantee tight quality control throughout their business
processes, in compliance with strict regulatory controls - from
material delivery, through production, packaging and distribution,
to worldwide customer service. Faced with the challenges of having
to achieve higher productivity, faster time-to-market and increased
return on investment, companies have placed their Quality
Management departments under increasing pressure to deliver
quality-related information to an enterprise-wide information
system. For a majority of organizations, the best solution is to
interface the SAP enterprise solution to the LIMS so that the LIMS
operates as a subsystem of the ERP. By interfacing LIMS with an
ERP, these organizations can expedite the data flow between the lab
and the manufacturing functions, streamline data handling, and
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integrate data collection and reports. Importance to be given to
selection of Implementation partner who will understand the
business process of both the systems and develop the interface in
accordance to the business requirement. While selecting the
implementation partner, considerations to be given to their skills in
lab automation practice, domain knowledge in the area of SAP and
LIMS, technical expertise in the area of Netwever and XI along
with techno functional knowledge in various LIMS. Unless
appropriate partner is not chosen, all the effort to make a uniform
integrated system will go in vein.
6.Reference:
=A Case Study in Harmonizing LIMS and ERP / MRP Systems
Autoscribe Ltd.
=http://www.erpgenie.com/sap/interfaces/
=R.D.McDowall, Scientific Computing & Instrumentation,
LIMS/Laboratory Informatics Guide, 2005.
=C.Kornbo and R.D.McDowall, Scientific Computing &
Instrumentation, LIMS Guide, 2002.
=Food and Drug Administration, current Good Manufacturing
Practice regulations, 21 CFR 211.
=European Union GMP, Annex 11 Computerised Systems,
2002.
=R.D.McDowall, Validation of Chromatography Data
Systems: Meeting Business and Regulatory Requirements,
Royal Society of Chemistry, 2005.
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7. About the author:
Somnath Mukherjee is head of
LI MS Pr a c t i c e a t HCL
Technologies Ltd. He has over 18
years of experience in the
development of LIMS, its
implementation and support
services. Somnath has worked in
almost all areas of LIMS, and he
specializes in the area of
interfacing LIMS with other
software in an enterprise. Prior to
joining HCL Technologies, he
worked with LabVantage Solutions. Somnath has a post graduation
degree in Chemical Technology and has written in multiple research
publications on system automatio