Nuances in ERP (SAP)

integration with LIMS

1. 32. Area of Interfacing 32.1. SAP QM and LIMS: 32.2. SAP MM and LIMS: 43. Different mechanism for Interfacing 53.1. SAP NetWeaver Process Integration for Enterprise Application Integration 6 3.2 Options within LIMS 74. Interface from Regulatory angle 7 5. Conclusion 86. Reference: 97. 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

4This 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

5Additional 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 LIMSMaterial Information Transferred to LIMS

Material Information Updated in LIMS Material Information Transferred to LIMS

Raise IndentIndent Information Transferred to SAP

Store PR and Indent Mapping in LIMS

PO information Stored inLIMS 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.

63.1. 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

7setup 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

8design 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

8integrate 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.

9Hello there. I am from HCL Technologies. We work behind the scenes, helping our customers to shift paradigms and start revolutions. We use digital engineering to build superhuman capabilities. We make sure that the rate of progress far exceeds the price. And right now, 55000 of us bright sparks are busy developing solutions for 500 customers in 17 countries across the world.

How can I help you?transform@hcl.in

7. About the author:

Somnath Mukherjee is head of L I M S P r a c t i c e a t H C L 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

Page 1Page 2Page 3Page 4Page 5Page 6Page 7Page 8Page 9Page 10