Introduction

The need for integration between the functions of Production and Quality has never been greater. In the chemical and pharmaceutical industries particularly, increasing demands on Production coupled with stringent Quality requirements means that it is no longer acceptable to maintain islands of information in areas that impact so heavily on each other. This has posed a significant challenge to IT functions within the manufacturing sector to facilitate integration through the seamless transfer of data between informatics systems and departments.

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. 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.

Integrating the Laboratory

One of the best established ERP solutions is provided by SAP AG (Walldorf Germany) and has been recently renamed from R/3 to R/3 Enterprise. Fully integrating product quality information from the lab within SAP Enterprise, via its QM (Quality Management) module, is a focus for both SAP and its customers. Though the QM module can perform some simple LIMS functions, its role is to maintain and communicate product quality data. This contrasts with the responsibility of a conventional LIMS, which is to collect, manipulate and communicate quality data.

Implementing a single system that appears to meet the requirements of the enterprise as a whole seems very appealing. However, laboratories are increasingly opting to implement specialist, functionally-rich 'enterprise-centric' LIMS products to achieve this. As a consequence, industry is exerting pressure on SAP and LIMS vendors such as Thermo Scientific to integrate and therefore aid organizations to make effective and rapid decisions concerning production processes and business functions.

ERP systems and LIMS, when used in combination, can be very powerful. QM maintains product information, test definitions, and quality specification limits.  With the help of other SAP modules, QM initiates quality inspections and transfers all of this information dynamically to the LIMS. LIMS will then process these quality inspections in great detail, recording and storing raw data and calculations used, and perform testing and other lab activities that are outside of the QM request. When ready, summarized results and statuses are uploaded to QM. In addition, the LIMS maintains a much higher level of detail about the inspection lot than QM is equipped to deal with. The LIMS also has the ability to automate the sample lifecycle in the lab, and produce high-level management reports where QM cannot.

Where there is no formal structure to the processing of samples or an organization does not operate a lab as such, the LIMS-type functionality of QM is perfectly adequate.  An example would be testing that occurs on the production line. If a bolt is taken out of a bin, measured then weighed, to take a simple example, neither a lab is involved nor is there a formal sample lifecycle. For organizations where sample tracking, automated test results entry from instruments, storage of more than just final results, and high level management reporting are required, a LIMS is necessary. Furthermore, if resource (ie, instrument calibration, training, chemical inventory), specialized testing (ie, dissolution, content uniformity), or specialized sampling (i.e., stability studies) are performed, a LIMS becomes essential for a laboratory to operate effectively.

Having embraced the approach of integrating ERP with LIMS, organizations are then left with the challenge of how best can they be made to work together, closely integrating products to exploit the benefits of laboratory automation and, ultimately, improve supply chain management.

Traditionally, LIMS/ERP integration projects have produced customized solutions that have been heavily dependent on site-specific requirements. This has naturally led to highly bespoke interfaces that differed greatly even among plants within the same organization. In an attempt to standardize on the mechanisms of exchanging data between their IT systems, users are increasingly calling for off-the-shelf integration products which may be applied directly to their integration needs.

To address the needs of large-scale production facilities, where integration with enterprise resource planning systems is a key business requirement, LIMS vendors are developing standard integration packages for their products. Thermo Fisher Scientific* offers such an interface program with the SAP QM module for its SampleManager™ enterprise LIMS called SM-IDI, which was the first LIMS interface certified by SAP.

There are a number of factors to consider when connecting a LIMS and an ERP module.  First, the organization needs to ensure that the LIMS is flexible enough to provide a toolkit to map the two applications. Second, the LIMS should provide the ability to relate these systems to the organization's business workflow.  And, finally, the interface needs to provide a proper translation of information between the disparate systems. 

New features delivered in the latest version of the SM-IDI interface solution enables users of the Enterprise QM module to fully utilize all the SAP QM functionality available. SM-IDI provides a simple point and click interface that allows either Enterprise or LIMS to be the creator of the data, while providing the user with the ability to map the critical business needs into the LIMS database.

SM-IDI uses SAP’s QM-IDI to communicate and exchange data with the QM module. A configurable interface such as SM-IDI maps SAP records and data elements into the LIMS tables and elements. QM-IDI provides a set of objects (ie folders) which are used to transfer data such as inspection plan and inspection data) between QM and LIMS applications. Through the use of graphical table-driven SAP objects and user-driven mapping procedures, SM-IDI ensures the LIMS user has easy access to only the information they require, while ensuring it is both accurate and in a format that can allow flexibility. Through manipulation and translation within SM-IDI, this information is presented to the LIMS user in a format and language that they can readily understand. When the LIMS user has entered inspection and the parameters are accepted, this data is converted back via SM-IDI into the SAP-required format and automatically sent to SAP QM, for further processing and integration with the rest of the Enterprise system.

Most importantly, when SAP Enterprise customers upgrade to a new version or customize their Enterprise deployment, there is now no requirement for a corresponding re-coding of SampleManager LIMS itself. Instead, simple updates are made to the table-driven SAP objects in SM-IDI in a matter of minutes.

In Summary

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, such as SM-IDI users Dow Chemical and Elan Pharmaceuticals, 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 integrate data collection and reports.

Author biography

Neil Millar is a Senior Software Engineer responsible for SAP to LIMS interfacing at Thermo Fisher Scientific, based in Altrincham, UK. He is responsible for co-ordinating SAP to LIMS implementation projects for customers in a variety of industry sectors, including pharmaceutical, and petrochemical production. The extent of his role is to liaise with customers on specific requirements for the management of the Quality Management module in SAP R/3 Enterprise.