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Siemens Industry Online Support
Siemens AG
Entry type: Application example, Entry ID: 109744244, Entry date: 05/16/2017
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GMP-compliant Configuration in WinCC Comfort/Advanced (TIA Portal)

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Detailed step-by-step instructions will show you how to configure the GMP requirements (e. g. creating an Audit Trail, recording user actions) in WinCC Comfort/Advanced (TIA Portal).

Industry sectors such as e. g. pharmaceutical industry or the food and beverage sector are subject to higher requirements with regard to the manufacturing process of the products. Thus, for example, the requirements of the guidelines concerning “good manufacturing practice” (GMP) must be adhered to in order to be authorized to manufacture the respective products. Thus, major operator actions have to be acknowledged and enabled by the user.



Solution
The options package WinCC Audit (TIA Portal) allows complete tracking and tracing of all user actions at the operator panel.
The solution presented here shows you how to create an Audit Trail and how to record quality-relevant user actions in the Audit Trail. You can configure tag value changes, recipe uses and various user actions with corresponding events. If these user actions are carried out in Runtime, they will be automatically recorded in the Audit Trail including a time stamp and the logged on user.
Moreover, you will learn how to view the Audit Trail using the "WinCC Audit Viewer" and how to evaluate it.

Documentation
  Documentation (2,3 MB)

Further Information
User administration in WinCC (TIA Portal) under entry ID 109738532
Panel Security Guidelines under entry ID 109481300

Additional Keywords
Good Manufacturing Practice, GMP, quality assurance, quality management

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