simatic hmi

HMI SoftwareSIMATIC WinCC OptionsFDA Options4■ Function (continued)Audit Trail database and Audit Viewer■ Ordering dataWinCC/AdvancedUser AdministratorAll modification data such as operator actions, configurationExtended user administration forchanges and document changes are stored in the Audit Trail database.The most important data fields in audit trail data are:WinCC V5.1• Engineering license for 1 project• Date and time of the modificationincluding 1 runtime license for• Object namean operator station, electricaldocumentation (Eng./Ger.)• Old value and new valueon CD-ROM• User name• Runtime license• Event/functionfor an operator station• Comment (reason for change)Central user managementfor WinCC V6.0, runtime licenseAudit trail data are visualized using the Audit Viewer. Users selectthe desired view of the audit trail data via filters and they canfor an operator stationexport the data to an Excel file. Audit trail data are falsificationproofSIMATIC Logon Serviceand can thus not be modified or deleted. WinCC Audit WinCC/Audittherefore also satisfies the FDA requirements to 21CFR Part 11 for WinCC V6.0 SP3in this respect.• WinCC/Audit RT V6.0 SP2 – CCreation of audit trails in RT• WinCC/Audit RC V6.0 SP2 – CConfiguration of audit trails withRT licenseOrder No.6DL5 401-8AX22-0XX06DL5 401-8AX22-0XX16ES7 658-7BX11-2YA06AV6 371-1DV06-0AX26AV6 371-1DV16-0AX2C) Subject to export regulations: AL: N and ECCN: EAR99S■ More informationInformation about FDA can be found in a White Paper:Declaration of conformity of SIMATIC WinCC toFDA21 CFR Part 11.Additional information can be found in the Internet under:http://www.ad.siemens.com/hmi/html_76/products/software/wincc/fda01.htm4/92Siemens ST 80 · 2006