L IMS: Enhanc Ed fE aturE S ➤
standard. Unilab also covers standard functionality to support PAT (Process Analytical Technology) for on- and at-line instrumentation integration, a growing requirement for implementing Quality by Design processes. The SAP Business Suite is completely
service-enabled. SOA is an important element of SAP’s strategy to provide an open framework for partners and customers to implement new or adapt existing business processes. Not many LIMS systems do support the ISA standards natively. Starlims natively supports web services. This allows individual services to be published and then used by third-party systems in an SOA-based environment. Thermo Fisher offers IntegrationManager, a middleware integration platform that supports bi-directional MES connectivity, SAP integration and CDS including Waters Empower, Chromeleon and Atlas. LimsLink of PerkinElmer will allow the configuration of interfaces that will permit the collection and exchange of ISA 88 and 95 message standards, including XML exchange. LabWare LIMS can both publish and consume web services and support SOA architecture. Many LabWare LIMS functions can be exposed as web services.
rEach REACH is the European law on chemicals and their safe use. One of the goals of REACH is to increase protection of human and environmental health. Most laboratories will include all the sample types, analytical methods, specifications, instruments, and so on in the LIMS. Several reports are mandated by the regulation including: Information to be submitted to the register; IUCLID 5 (International Uniform Chemical Information Database); Safety Data Sheets; and labels. With PerkinElmer LIMS, any
chemical utilised or analysed in the laboratory can have a unique chemical name, synonym, CAS number, EPA Storet number, pictogram for hazards, MSDS, chemical formula, or molecular model. It allows users to access and link to documentation easily,
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concerning chemicals and reagents used in the laboratory. When managing suppliers and incoming goods, Starlims allows for the supplier to submit test results with the material. Additional documentation from the
supplier maybe attached to the material. This allows for test results related to the measurement of the concentration REACH substances to be provided in
‘thE SuBStancE LIMS EntIty aggrEgatES
thE hazardS, rISkS, handLIng and LaBELLIng data’
electronic form, as well as for a certificate of compliance to accompany the material. Within Thermo Scientific LIMS, the properties, hazards, labelling and MSDS requirements of substances used in the laboratory are recorded in a single record. The substance LIMS entity aggregates the hazards, risks, handling and labelling data required for any materials that are used in the laboratory process. Stock management functionality can be used to record the usage of all hazardous materials used in the laboratory, as well as all the components used to manufacture individual products, thus enabling the review of materials that require registration under REACH. In the event of a dangerous substance being substituted under REACH
regulations, the LIMS explorer would identify remaining stock levels, location of material for collection and disposal, and analysis methods that require updating to use alternative chemicals. In Simatic IT Unilab, material Safety Data Sheets can be linked as a document to the sample types. Safety tests can be configured as mandatory tests to be executed when handling the specific materials. Stock management of standards/reagents is also handled. REACH compliance management from SAP supports the supply chain communication process related to the exchange of use and Exposure Scenario information and the organisation of the REACH registration process for the substances. The system determines the materials that are relevant for the REACH regulation and how the materials are affected by the REACH regulation. To request information on uses of materials from your customers or from suppliers, you can use campaigns. The information on uses provided by the system after a successful aggregation of material data is automatically transferred to the substances you need to register. Registration management supports you in organising your registrations for each legal entity. In many countries, regulations like
REACH state that, above a certain quantity of chemicals and other hazardous substances, you must register with the authorities the maximum quantities of these substances that you plan to purchase, import, produce, sell, or export within a certain period. Substance volume tracking helps you to comply with the relevant regulations by recording the quantities of substances needing to be tracked that you purchase, import, produce, sell, or export. By comparing the recorded quantities with the limit values, the system can warn you in good time before a limit value is exceeded; if a limit value is exceeded, the system can block the respective business process.
Smart LIMS Environmental safety report. A picture is worth a thousand words (green is safe; red is contaminated) – courtesy Vialis AG
● Peter Boogaard is an independent LIMS consultant: peterboogaard@
industriallabautomation.com.
L IMS: Enhanc Ed fE aturE S
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