WinCC Audit covers essential requirements outlined by GMP (Good Manufacturing Practice) and the FDA (Food and Drug Administration) in accordance with 21 CFR Part 11.
WinCC Audit facilitates the construction of machines for industries with applications that require validation, because important functions for fulfilling these requirements are already provided by default and, in this way, individual machines or plant units can be qualified in advance at the supplier's end.
At the same time, Audit Trails are also suitable for tracking production processes for increasing product quality, as stipulated, for example, in EC Directive 178/2002 for the food and beverages sector.
Recording of operator actions in Audit Trails
In process operation, all GMP-relevant changes to tags and any operator actions are recorded as Audit Trails in a CSV file. Such operator actions can be, for example, the input of process values, the starting of recipes, or an alarm acknowledgment, but also alarms from the user administration, such as the logging on or off of a user. This shows exactly who operated what and when – with minimal configuration overhead. In addition, a checksum procedure is used to check that the data in the Audit Trail has not been manipulated. The Audit Trails can also contain Asian texts, which can be printed directly from the panel.
Logging and reporting
Depending on the requirement, WinCC Audit allows the logging and reporting to be done locally, i.e. in the HMI device, or centrally in distributed systems, e.g. in a PC in a local controlroom. This supports solutions for the long-term archiving and restoration of the data.