WinCC/Audit

Tracing operator inputs and project changes

Description

WinCC/Audit is for monitoring changes in operator activities in runtime operation as well as for recording project changes at the engineering stage. The system records all the change data in a secure database known as the Audit Trail. You can view the Audit Trail using the Audit Viewer.

This means that using WinCC/Audit provides continuous traceability of both operator activities and changes to projects and, at the same time, also helps machine tool builders and plant operators to reduce the amount of engineering time and effort involved in complying with the requirements of 21 CFR Part 11 and EU 178/2002. The engineering measures that are necessary for making validation easier are documented in a white paper.

Benefits

  • Reliable recording of operator actions and project changesin Audit Trails

  • Project versioning and document control  

  • Compliant with the requirements of the FDA (Food and Drug Administration)  

  • Reduced engineering effort to comply with 21 CFR Part 11 & EU 178/200

WinCC components supporting GMP

Design and functions

Monitoring runtime operation

In runtime operation the system records the following in the audit trail:

  • Operating activities carried out,

  • Activities within the scope of central user management using SIMATIC Logon  

  • Starting and changing recipes

Apart from this, plant operators can individually record specific events by means of an audit entry function:

  • Operation of pushbuttons and sliders  

  • Record Pressing of a key

Audit Trail database and Audit Viewer

The Audit Trail database stores all the change data that is subject to document control; this includes user actions, confi guration changes and other changes. Components of Audit Trails include:

  • date and time of the change

  • project ID, PC and database name  

  • old value and the new one

  • user name

  • event/function

  • Comment/reason for change

The system visualizes the Audit Trail data by means of the Audit Viewer. Operators use filters to selectively set the desired view of the Audit Trail data and they can export this data to an Excel file. The Audit Trail data is stored securely on a tamper-proof basis and this means that you cannot change or delete it.

This means that WinCC/Audit meets the FDA requirements of 21 CFR Part 11 in this respect too.

Tracking project changes

Monitoring project changes is possible with WinCC/Audit and with the option package WinCC/ChangeControl as well. In this connection, WinCC differentiates between configuration changes that affect the WinCC database, e.g. changes in Tag Management or creating a user group and configuration changes that are limited to changes to files, what is known as document control. Document control involves process pictures, scripts and log layouts and customer-specific documents. This means that WinCC/Audit can monitor all these documents or files for changes, create intermediate versions or retrieve them using a rollback function. The entire monitoring process can be activated very easily and conveniently. This means that in the case of plant standstills, for example, plant engineers and operators can quickly and easily comprehend the changes that have been made to the plant. This supports trouble-shooting and reduces plant downtimes.

WinCC/ChangeControl

Using a project versioning tool 

  • WinCC projects can be archived, restored and deleted,  

  • WinCC data including the project database, project files (e.g. screens, reports, scripts) and user documents can be archived

  • Activities of the project versioning tool can be recorded  

In this way all changes made to a plant beginning from the production start and continuing throughout the entire life cycle can be recorded and - using defined versions - be documented.