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WinCC -- Product information -- Technical data
What support does Siemens AG offer to make products comply with FDA regulations?
What support does Siemens AG offer to make use of WinCC comply with FDA regulations?
WinCC User Archive -- Product information -- Technical data
What support does Siemens AG offer to make products comply with FDA regulations?
What support does Siemens AG offer to make use of WinCC comply with FDA regulations?
Why can't I use the User Archive with password protection unrestricted in Client-Server mode?
Is a SIMATIC WinCC User Archive with a limited number of records (archive type: Limited) a circulation archive?
WinCC SIMATIC Logon / AUA -- Product information -- Information on SIMATIC Logon / Advanced User Administrator
Using a chip card reader, how can a default user be logged on automatically while the chip card is pulled through?
What support does Siemens AG offer to make products comply with FDA regulations?
What support does Siemens AG offer to make use of WinCC comply with FDA regulations?
How can you configure a chip card with SIMATIC Logon, with which you can log onto each local computer?
Why isn't the group selection dialog displayed any longer in WinCC V6.2 and higher?
How can you use the "GetSignature" function as of SIMATIC Logon V1.4?
What is the standard password of the user "Administrator" in the WinCC User Administrator?
Why isn't the user currently logged on shown at Runtime?
How can you replace the Windows on-screen keyboard of SIMATIC Logon (from V1.4) with the ProTool keyboard so as not to reach the operating system during Runtime?
How can you verify a logged on user at runtime when using SIMATIC Logon (as from V1.3)?
How can you verify a logged on user at runtime when using SIMATIC Logon up to version V1.2 SP1?
How do you call the SIMATIC Logon dialog box by means of C-Script?
The WinCC Login Box appears instead of the Logon Box in WinCC Runtime.
WinCC / Audit -- Product information -- Information on WinCC Audit / ChangeControl
What support does Siemens AG offer to make products comply with FDA regulations?
What support does Siemens AG offer to make use of WinCC comply with FDA regulations?
Important note for the work with dublicated SIMATIC WinCC/Audit V6.0 Projects
What support does Siemens AG offer to make use of WinCC comply with FDA regulations?
Part number:

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

 Entry ID:37940022   Date:2013-08-29 
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