Nuremberg, 07.04.2003

Laboratory Information Management System with a lot of new and extended functions

At Anuga FoodTec, as indeed at Achema, Siemens Automation and Drives (A&D) will be presenting its new release 5.0 of LIMS-(Laboratory Information Management System)-Software: Simatic IT Unilab V 5.0 is integrated into Siemens´ MES-(Manufacturing Execution Systems)-Software Simatic IT and comes with a lot of new and extended functions. Simatic IT Unilab is available as a component of Simatic IT or as a stand-alone LIMS, that can be easily configured to comply with specific needs of each laboratory - for Quality Control, Central Services and R&D. Simatic IT Unilab V 5.0 offers enhanced performance and more advanced web functionality, also compliancy to the FDA's 21 CFR 11 (or write Part entirely) regulation for electronic records and signatures and industry standards, such as ISO/IEC 17025. The new version offers as well as increased instrument connectivity, the possibility to connect handheld devices as pocket PC and tablet PC and a cost calculation module for invoicing and quotations. Furthermore Simatic IT Unilab V5.0 introduces a stability module to support stability testing of substances under environmental factors.

With the native web user interface, LIMS users can create analysis requests for samples, view requests for analysis, enter analysis results and view the status of results via a web browser. By web, quality and sample information is available in no time for the complete manufacturing environment, both within the plant, the enterprise or even the supply chain. For independent labs, this means that information is available for customers at any time, increasing substantially the level of customer service.

The new version offers also full compliance to the FDA's 21 CFR Part 11 regulations for electronic records and signatures. Access to the LIMS, electronic signatures, specification and test protocol changes, data input corrections, etc. can all be controlled conform the customer's needs and in support/compliance with 21 CFR Part 11 regulations. Laboratories working with mobile workforces now also have the possibility to automatically transfer data collected on the 'field' in a sterile environment or at a remote production line with a tablet or pocket pc into the LIMS-system. This avoids having to write down raw data first and in a second phase having to introduce it into the LIMS-system, which saves time and prevents errors.

The extended Uniconnect module, that allows instruments - e.g. scales, GC'sor HPLC's - to be connected with the LIMS in order to automatically transfer data, has been optimised to increase the number of instruments that can be connected. The new stability module is of particular interest to the pharmaceutical industry. The purpose of stability testing is to provide evidence on how the quality of a substance - e.g. drugs or food - varies with time under the influence of environment factors or conditions such as temperature, humidity and light. Stability testing can be done as part of the introduction of new substances, but also in case of a new dosage form - e.g. a different administration rout, new specific functionality/delivery systems and different dosages forms

Specifically for independent or commercial labs, e.g. governmental labs, environmental labs, animal health labs or service labs for manufacturing environments, Simatic IT Unilab V5.0 offers a new cost calculation module. With this module, it is possible to calculate the cost of a request of analysis arriving in the lab based on price catalogues and provide accounting departments with invoice details for the particular request of analysis, thus automating the process of invoicing the lab customer.

Additional information is available on the Internet at: www.simatic-it.de

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