Later, with the rapid development of computer technology, all the operations in the field were realized by the upper computer, such as starting the equipment and changing the formula value. At this time, the traditional operation recording method is out of date. For this reason, the US FDA (US Food and Drug Administration) has specially promulgated relevant laws and regulations, namely 21cfrpart11:electronic data record and electronic signature, which are used to standardize the management of traceable records under the new situation. The following basic requirements are derived from this regulation:

Run-time creates inspection trace and operation trace.

Important processing stages must also be able to trace the specific person in charge, such as using electronic signatures.

Simply put, it is to record the operator's operation on the field equipment in the form of electronic documents, and for important operations, it will also record the operator's name, that is, electronic signature.

I won't say much about the specific configuration of Audit here. It's simple. When using, please refer to the contents under Check Options in WinCCflexible Help. Let's look at the effect of auditing electronic records:

Using the AuditViewer software that comes with WinCCflexible to open the record file, you can clearly see the system information recorded by the system (such as starting and stopping the system) and the operator's operation information on the system (such as modifying variable values).

Someone wants to ask, can't this document be revised? This file format is CSV or TXT, which can be modified, but if it is modified, the green light on the left side of the screen will turn red, telling you that the file has been tampered with.

Actually, it's not like this. FDA certification is an independent science, which is generally carried out by professional companies or personnel. The function of WinCCflexilbe and related software is to provide some ready-made functions to meet the specific requirements of relevant FDA regulations (Siemens has corresponding information to explain how to meet the requirements). For example, if you want to drive from Beijing to Shanghai, we have provided you with a car with excellent performance, but you still need to drive yourself or hire a professional driver.