SAP ERP is used almost in all chemical/petrochemical and pharmaceutical companies world-wide. By the use of the QM module a broad variety of functionality is achieved, which formerly was reserved for the traditional Laboratory Information and Management Systems. However, the SAP QM module provides no facilities for a direct link to the level of laboratory equipment; thus, in the regulated area this system is limited in acceptance.
The new Middleware LABS/QM offers the possibility to connect any measuring device or analytical system directly to the SAP QM. Therefore, errors caused by manual data entry are entirely excluded, and, in this way a GxP/FDA compliant workflow is achievable. In addition, the Middleware LABS/QM increases the automation level in the laboratory, thus leading to an improved efficiency of the employees, resultingin cutting the costs of the entire laboratory workflow.
The information on the SAP inspection lot is directly converted by the Middleware LABS/QM to a suitable data format for analytical instruments and systems. For example, this information can be used for generating sequences for all common chromatographydata systems, like Agilent Chemstation, Cerity, EZChrom Elite, OpenLAB CDS Chemstation & EZchrom Edition and Galaxie, Bruker compassCDS, Jasco Chrompass, Perkin Elmer Turbochrom and Totalchrom, Thermo Dionex Chromeleon, and Waters Empower. In addition, the derived data are suitable as sample information for a variety of further analytical instruments and control software, e.g. for IC, ICP, AAS, IR,NIR, elemental analysers and many others. Addionally to analytical systems with a complex structure as mentioned above, even simple laboratory devices can be connected directly to SAP QM via LABS/QM, e.g. scales, gauges, or automatic titrators.
After completing the measurement and performing a review within the analytical control software, the results are automatically transferred to the Middleware LABS/QM for additional calculations and conversions, e.g. taking references, blanks, or control samples, etc. into consideration. Thereafter, the analytical data are transferred directly to the inspection lot/test unit of SAP QM, where the final evaluation of the results is achieved and usage decision takes place.
Linking the Middleware LABS/QM with one or more SAP QM systems is managed via WEB services by exchanging data with the SAP WEB Server Netweaver and its standard communication software exchange infrastructure (PI). By buffering information in the Middleware LABS/QM, both, online as well as offline operation is possible. This will ensure 24/7 availability for inspection and documentation even if SAP is not available.