Entry type: FAQ, Entry ID: 37940022, Entry date: 08/29/2013
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What support does Siemens AG offer to make use of WinCC 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 in WinCC
WinCC provides the following options and solutions to fulfill the FDA regulations:

  • Access protection
  • Audit Trail
  • Data archiving and retrieving
  • Electronic signature

Access protection (Runtime)
Access protection is ensured by the software package SIMATIC Logon.
Below are examples of fulfilled requirements.

  • 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

More information on the topic of SIMATIC Logon is available here.

Audit Trail (Engineering and Runtime)
The Audit Trail is provided by the option WinCC/Audit. WinCC/Audit is for monitoring operator activities in Runtime mode and during the Engineering phase.
Below are examples of fulfilled requirements.

  • Process data (defined process values and defined process and operator messages, for example) is stored without the operator being able to make any changes.
  • Relevant changes made by the operator in the process visualization system during operation are recorded in an Audit Trail.
  • Changes in the user administration are recorded by WinCC/Audit.

More information on the topic of WinCC/Audit is available here.

Data archiving and retrieving (Runtime)
WinCC has a configurable and scalable archiving concept. WinCC permits you to use local archives to record messages and process values. You can retrieve the collected data at any time during the complete retention period. The WinCC premium add-on "PM Quality" provides another option. More information on the WinCC premium add-on "PM Quality" is available here.

Electronic signature (Runtime)
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.

Additional information about the electronic signature is available in the sample application "Configuring electronic signatures in SIMATIC WinCC" in Entry ID: 67688514

Further information
More information on the topic of GMP (Good Manufacturing Practice) is available at the following link:
GMP Webcast & Testimonials

Additional Keywords
Certificate, Directives, Laws