{\rtf1\ansi\ansicpg1252\uc0\deff0{\fonttbl {\f0\fswiss\fcharset0\fprq2 Arial;} {\f1\froman\fcharset2\fprq2 Symbol;}} {\colortbl;\red0\green0\blue255;\red255\green255\blue255;\red0\green0\blue0;} {\info{\*\hlinkbase e:\\Medaps\\CA01_Generate\\export\\CA01_ENG_INT_IK_05102004\\rtf\\}{\comment TX_RTF32 8.0.300.500}} \deftab708\paperw15309\paperh16840\margl1134\margt1134\margr3430\margb1338\pard\sb60\sa20\plain\f0\fs18\b\cf1 SIMATIC Logon Service and WinCC/Advanced User Administrator\par\pard\sb100\plain\f0\fs18 The options feature numerous security mechanisms, both for administrators and users. Users receive a unique user ID, user name and password. This information is stored encoded at a central location (in the case of AUA, in its own database, and with the SIMATIC Logon Service, in the Windows user management). Functions such as aging of the password, automatic log-off after a pre-defined time, and blocking following repeated entry of an incorrect password guarantee the highest level of operational security.\par In the case of the SIMATIC Logon Service, the user administration is integrated into the security system and user administration of MS Windows.\par To meet, in particular, the Food and Drug Administration (FDA) requirements for the pharmaceuticals and food processing industry, all user and administrator actions, such as logging in, logging out, password changes, incorrect password inputs, and creating and deleting users, are recorded with timestamp in a secure database. A log file in ASCII format can be generated for analysis.\par In addition, Advanced User Administrator and SIMATIC Logon Service allow the administrator to set up new users online, plant-wide and across applications, or to block existing users. SIMATIC Logon Service also supports electronic signature.\par\par\pard\sb60\sa20\plain\f0\fs18\b\cf1 WinCC/Audit\par\pard\sb100\plain\f0\fs18 WinCC Audit is used for monitoring changes both of operator actions in the RT area and during the engineering phase for recording changes to the configuration. All change data are recorded in a falsification-proof database called the Audit Trail. The user visualizes the Audit Trail using the Audit Viewer. WinCC WinCC Audit's functions support plant and mechanical equipment manufacturers, and help operators to meet the requirements of FDA 21 CFR Part11. \par\pard\sb60\sa20\plain\f0\fs18\b\i\cf1 Monitoring RT operation\par\pard\sb100\plain\f0\fs18 As well as recording operator activities, the Audit Trail also captures the starting and modifying of recipes (customized tables). In addition, plant operators can use an Audit Entry function to also record entirely individual activities, such as pressing a button in the Audit Trail, on specific objects or events such as function keys, slides and others.\par\par\pard\sb20\sa20 {\field{\*\fldinst INCLUDEPICTURE "S_ST80_XX_00020.JPG"}{\fldrslt {}}}\par\pard\sb100\par\pard\sb60\sa20\plain\f0\fs18\b\i\cf1 Monitoring configuration changes\par\pard\sb100\plain\f0\fs18 WinCC Audit differentiates here between configuration changes that modify the WinCC database or that are carried out via the WinCC Explorer, such as changes to variables or the creation of a user group, and those that are limited to the modification of files, referred to as document check. The document check covers plant pictures, scripts, and log layouts, and customer-specific documents. That is, all these documents or files can be monitored for changes by WinCC Audit, and intermediate versions can be created or fetched back using the rollback function. Overall, monitoring can be configured extremely simply and in a user-friendly and integrated way. \par\par\pard\sb20\sa20 {\field{\*\fldinst INCLUDEPICTURE "S_ST80_XX_00021.JPG"}{\fldrslt {}}}\par\pard\sb100\par Plant builders and plant operators can thus quickly and easily understand which changes have been made to the plant in the case of a plant standstill, for example. This provides support in plant analysis and reduces plant downtimes.\par\par\pard\sb60\sa20\plain\f0\fs18\b\cf1 Audit Trail database and Audit Viewer\par\pard\sb100\plain\f0\fs18 All modification data such as operator actions, configuration changes and document changes are stored in the Audit Trail database. The most important data fields in the Audit Trail are:\par\pard\fi-284\li284\sb60\tx284\plain\f1\fs18 \'b7\plain\f0\fs18\tab Date and time of the modification\par\plain\f1\fs18 \'b7\plain\f0\fs18\tab Object name\par\plain\f1\fs18 \'b7\plain\f0\fs18\tab Old value and new value\par\plain\f1\fs18 \'b7\plain\f0\fs18\tab User name\par\plain\f1\fs18 \'b7\plain\f0\fs18\tab Event/function\par\plain\f1\fs18 \'b7\plain\f0\fs18\tab Comment (reason for change)\par\pard\sb100 The Audit Trail data are visualized using the Audit Viewer. Users select the desired view of the Audit Trail data via filters and they can export the data to an Excel file. The Audit Trail data are falsification-proof and can thus not be modified or deleted. In this respect too, WinCC Audit fulfils the FDA requirements in accordance with 21CFR Part 11.\par\par\pard\sb20\sa20 {\field{\*\fldinst INCLUDEPICTURE "S_ST80_XX_00018.JPG"}{\fldrslt {}}}\par\pard\par }