R. STAHL HMI Systems' compact operator interfaces in combination with an OPCom-FDA-Server and a suitable database support complete, traceable and manipulation-proof documentation of all operating processes. They are available in distinct performance classes, with or without ex-protection. The Falcon series, which includes text terminals and simple graphic interfaces is suitable for small to medium-sized operating tasks. In its turn, the powerful Eagle series also offers various functions for simple process visualization processes. In plants that are subject to validation, such as tank farms, IT-based automation systems have to adhere to specific regulations concerning access control, version control and data records. The relevant regulations are described, for example, in guideline FDA-21-CFR Part 11 ("Electronic Records, Electronic Signatures"), in Annexe 11 ("Computerized Systems") of the EC/EU guidelines for pharmaceutical products, in the GAMP 4.0 regulations issued by the ISPE as well as in other, similar guidelines and regulations. In parallel to an interface to the automation system, STAHL's operator interfaces communicate directly via Ethernet or the PLC with an OPC workstation in the network. At this workstation, a specifically developed OPCom-FDA-Server is used to authorize access or, where necessary, to authenticate and record electronic user signatures. For this, the server receives input from the operator interfaces and then consults a customer-specific central user administration. During this process, electronic signatures and electronic records can be transferred to an existing SQL database via an ODBC interface, for example.
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