Entry type: FAQ, Entry ID: 37940461, Entry date: 08/29/2013
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What support does Siemens AG offer to make use of WinCC Runtime Advanced, WinCC Runtime Professional and panels that can be configured with WinCC (TIA Portal) comply with FDA regulations?

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Description
A general description on the subject of the Food and Drug Administration is available in Entry ID: 37939948.

Solutions
WinCC (TIA Portal) provides the following options and solutions to fulfill the FDA regulations:

  • Access protection
  • Audit Trail
  • Electronic signature
  • Possibility to identify tags as "GMP-relevant"
  • Possibility to identify recipes as "GMP-relevant"
  • NotifyUserAction system function
  • Archiving tags with checksum
  • Archiving messages with checksum
  • Audit Trail protocol for printing out archived changes

Stainless steel fronts (panels)
Devices with stainless steel fronts have the following special features:

  • Front (stainless steel 1.4301, polyester foil)
  • Surface (brushed finish, 240 grit, EPDM gasket)
  • Optimized frame profile
  • Sloping surfaces without front-mounted USB interface
  • Rear-mounted tensioning frame

Access protection (Runtime Advanced and Panels)
Access protection is ensured by the software package SIMATIC Logon (central user administration) and the local user administration.

The local user administration includes the following function:

  • The individual users and their assignment to user groups are defined in the WinCC Advanced configuration.
  • Authorizations with authorization levels based on the user groups are defined in the user administration of WinCC Advanced.
  • Password aging is supported; you can configure the length of password validity and the number of generations.
  • The user logged on is automatically logged off by the system after a configurable period of time if there is no activity during that time.

Access protection with SIMATIC Logon (Runtime Professional, Runtime Advanced and Panels)
Functions of user administration with SIMATIC Logon:

  • The administrator ensures central user administration (enabling, disabling, locking, unlocking, assigning to user groups).
  • Unique combination of user ID and password.
  • Definition of access rights for groups and users.
  • Password aging
  • Initial password
  • The user is blocked automatically after a configurable number of failed log-on attempts and can then only be unblocked by the administrator.
  • Automatic log-off
  • Log functions

Additional information on the topic of SIMATIC Logon is available in the manual WinCC Advanced V12 in the section entitled: "Visualizing processes (Comfort/Advanced) > Creating a User Administrator > Administrating users on the server"

Audit Trail (Runtime Advanced and Panels)
Runtime user actions and system procedures relevant for FDA compliance are stored in the Audit Trail.

User actions like changing of GMP-relevant tags are stored in the Audit Trail.
System actions (system procedures) like starting and stopping Runtime are stored in the Audit Trail.

Additional information on the topic of Audit Trail is available in the manual WinCC Advanced V12 in the section entitled: "Visualizing processes (Comfort/Advanced) > Options > Using Audit in compliance with GMP > Basics > Audit Option"

Electronic signature (Runtime Advanced and Panels)
In the WinCC Advanced Runtime you can make important user actions subject to signature, like the changing of recipe data, for example.
The electronic signature may consist of entering a password and a comment. The changes are recorded in the Audit Trail.

Additional information on the topic of the electronic signature is available in the manual WinCC Advanced V12 in the section entitled: "Visualizing processes (Comfort/Advanced) > Options > Using Audit in compliance with GMP > Basics > Audit Option"

Electronic signature (Runtime Professional)
SIMATIC Logon provides an interface (API) for configuring the electronic signature in WinCC. The electronic signature is ensured by SIMATIC Logon. The password and user ID are asked for.

Further information
More information on the topic of GMP (Good Manufacturing Practice) is available at the following link:
http://www.industry.siemens.com/verticals/global/en/pharma-industries/gmp-validation/Pages/Default.aspx

Additional information about Option Audit and GMP-conformity in WinCC Advanced is available in the manual WinCC Advanced V12 in the section entitled: "Visualizing processes (Comfort/Advanced) > Options > Using Audit in compliance with GMP"

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