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WinCC flexible RT -- Product information -- General information
What support does Siemens AG offer to make products comply with FDA regulations?
Why does the "Lock program switching" function no longer work after upgrading from SIMATIC WinCC flexible Runtime 2008 SP2 to SP3?
What new features do Intel® Atom™ processors have and what advantages do SIMATIC IPCs with Intel® Atom™ processors offer when used with SIMATIC software?
Which licenses do you need to upgrade from WinCC flexible 2008 or WinCC V7 to WinCC V11 and in WinCC V11?
What should you watch out for when installing WinCC flexible 2008 SP3 or WinCC V11 SP2 on an HP notebook?
How resistant to chemicals are the SIMATIC HMI operator panels and Industrial PCs?
What options are there for creating a screenshot in WinCC flexible ES, WinCC flexible Runtime or on panels?
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
What should you watch out with regard to licenses for WinCC flexible and panels?
How do you have csv archive files exported from WinCC flexible RT or a panel displayed graphically on the PC?
Which ports are used by WinCC flexible?
WinCC flexible Options -- Product information -- WinCC flexible /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 flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
What should you watch out with regard to licenses for WinCC flexible and panels?
Why does the message appear in the Configuration View indicating that there is no license for the "Change Control" option?
WinCC flexible Options -- Product information -- WinCC flexible /Archives
What support does Siemens AG offer to make products comply with FDA regulations?
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
How do you have csv archive files exported from WinCC flexible RT or a panel displayed graphically on the PC?
What should you watch out with regard to licenses for WinCC flexible and panels?
WinCC flexible Options -- Product information -- WinCC flexible /Recipes
What support does Siemens AG offer to make products comply with FDA regulations?
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
What should you watch out with regard to licenses for WinCC flexible and panels?
WinCC flexible Options -- Product information -- WinCC flexible /Audit
What support does Siemens AG offer to make products comply with FDA regulations?
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
What should you watch out with regard to licenses for WinCC flexible and panels?
How can you prevent Telnet access when using the WinCC flexible option Audit on a panel?
How can you display user actions and production data from the Audit Trail file on a panel?
WinCC flexible Options -- Product information -- WinCC flexible / ProAgent
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
What is the remedy if you cannot run diagnostics via ProAgent on the operator panel?
What should you watch out with regard to licenses for WinCC flexible and panels?
WinCC flexible Options -- Product information -- WinCC flexible /SIMATIC Logon
What support does Siemens AG offer to make products comply with FDA regulations?
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
What should you watch out with regard to licenses for WinCC flexible and panels?
Basic Panels -- Product information -- Technical data and ordering information
How do you load the 3D, CAx and ePLAN data for the SIMATIC products?
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
Which frame colors are used for the SIMATIC Panels and SIMATIC Panel PCs?
How resistant to chemicals are the SIMATIC HMI operator panels and Industrial PCs?
Which SIMATIC Panels have the CCC certificate?
Wich protective films can I use with SIMATIC HMI panels?
Where are the current declarations of conformity to be found for SIMATIC HMI panels (CE, UL, cUL, GOST)?
How can you determine the "E-Stand" (hardware release) of an operator panel?
What is the power consumption or power dissipation of the SIMATIC HMI operator panels?
What connections are there between the version designations in WinCC flexible?
Which PROFINET services are supported by SIMATIC panels.
What are the functional differences between the different SIMATIC panels?
Why is an Open Source CD supplied with the operator panel?
What support does Siemens AG offer to make products comply with FDA regulations?
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?
Which panels are certified for shipbuilding?
What should you watch out with regard to licenses for WinCC flexible and panels?
What options exist for ordering missing plug-in terminal strips for the power supply of panels?
Which Siemens department holds the EC conformity declarations for SIMATIC HMI?
Touch Panel / Operator Panel -- Product information -- Technical data and ordering information
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
Which frame colors are used for the SIMATIC Panels and SIMATIC Panel PCs?
Which SIMATIC Panels have the CCC certificate?
Wich protective films can I use with SIMATIC HMI panels?
Where are the current declarations of conformity to be found for SIMATIC HMI panels (CE, UL, cUL, GOST)?
How can you determine the "E-Stand" (hardware release) of an operator panel?
What is the power consumption or power dissipation of the SIMATIC HMI operator panels?
Which PROFINET services are supported by SIMATIC panels.
Which panels and flat screens does Siemens currently offer for hazardous areas with potentially explosive atmosphere (Ex2/22)?
How resistant to chemicals are the SIMATIC HMI operator panels and Industrial PCs?
Why is an Open Source CD supplied with the operator panel?
Which panels does Siemens currently offer with stainless steel fronts (INOX)?
What support does Siemens AG offer to make products comply with FDA regulations?
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?
What are the order numbers for the backup batteries and accumulators for the operator panels?
Which panels are certified for shipbuilding?
Which panels are certified for the FM explosion protection standard for North America?
Which protective covers are available for panels?
Which Siemens department holds the EC conformity declarations for SIMATIC HMI?
What options exist for ordering missing plug-in terminal strips for the power supply of panels?
Multi Panel -- Product information -- Technical data and ordering information
Which PROFINET services are supported by SIMATIC panels.
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
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?
Which frame colors are used for the SIMATIC Panels and SIMATIC Panel PCs?
Which panels are certified for the FM explosion protection standard for North America?
How resistant to chemicals are the SIMATIC HMI operator panels and Industrial PCs?
Which panels and flat screens does Siemens currently offer for hazardous areas with potentially explosive atmosphere (Ex2/22)?
Wich protective films can I use with SIMATIC HMI panels?
How can you determine the "E-Stand" (hardware release) of an operator panel?
What is the power consumption or power dissipation of the SIMATIC HMI operator panels?
Where are the current declarations of conformity to be found for SIMATIC HMI panels (CE, UL, cUL, GOST)?
The C7 6xx complete devices are to be discontinued in October 2010 – what are their successors?
Which panels does Siemens currently offer with stainless steel fronts (INOX)?
What support does Siemens AG offer to make products comply with FDA regulations?
What are the order numbers for the backup batteries and accumulators for the operator panels?
Which panels are certified for shipbuilding?
How do you replace a faulty operator panel, or where can I have a faulty device repaired?
Different sized projects for MP270 devices
Which protective covers are available for panels?
What options exist for ordering missing plug-in terminal strips for the power supply of panels?
Which SIMATIC Panels have the CCC certificate?
Which Siemens department holds the EC conformity declarations for SIMATIC HMI?
Mobile Panels -- Product information -- Technical data and ordering information
How do you load the 3D, CAx and ePLAN data for the SIMATIC products?
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
Wich protective films can I use with SIMATIC HMI panels?
Where are the current declarations of conformity to be found for SIMATIC HMI panels (CE, UL, cUL, GOST)?
What should you watch out for when connecting the equipotential bonding to the connection box of a mobile panel?
How can you determine the "E-Stand" (hardware release) of an operator panel?
What is the power consumption or power dissipation of the SIMATIC HMI operator panels?
Which PROFINET services are supported by SIMATIC panels.
How resistant to chemicals are the SIMATIC HMI operator panels and Industrial PCs?
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?
Which panels are certified for shipbuilding?
What should you watch out with regard to licenses for WinCC flexible and panels?
How do you incorporate the execution times of the F blocks for the Mobile Panel 277F IWLAN into the "S7fcotia.xls" table?
Which installation guidelines do you have to watch out for with the transponders for the Mobile Panel 227 IWLAN and the Mobile Panel 277F IWLAN?
Mobile Panel 170 can only be used with the connection box
Which Siemens department holds the EC conformity declarations for SIMATIC HMI?
Which SIMATIC Panels have the CCC certificate?
Which SIMATIC panels have or need an FCC certificate?
Why is there no yellow-and-red emergency stop button on the tethered-connection mobile panel?
No standard project in WinCE devices
Micro Panels -- Product information -- Technical data and ordering information
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
Which frame colors are used for the SIMATIC Panels and SIMATIC Panel PCs?
Where are the current declarations of conformity to be found for SIMATIC HMI panels (CE, UL, cUL, GOST)?
What are the resolutions and mounting positions of the various HMI Panels and Panel PCs?
Wich protective films can I use with SIMATIC HMI panels?
What connections are there between the version designations in WinCC flexible?
How resistant to chemicals are the SIMATIC HMI operator panels and Industrial PCs?
What support does Siemens AG offer to make products comply with FDA regulations?
Which panels are certified for shipbuilding?
Which panels are certified for the FM explosion protection standard for North America?
What should you watch out with regard to licenses for WinCC flexible and panels?
Which Siemens department holds the EC conformity declarations for SIMATIC HMI?
Which panels and flat screens does Siemens currently offer for hazardous areas with potentially explosive atmosphere (Ex2/22)?
What options exist for ordering missing plug-in terminal strips for the power supply of panels?
Which protective covers are available for panels?
Pushbutton Panels -- Product information -- Technical data and ordering information
How do you load the 3D, CAx and ePLAN data for the SIMATIC products?
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?
Which frame colors are used for the SIMATIC Panels and SIMATIC Panel PCs?
Which panels are certified for the FM explosion protection standard for North America?
How resistant to chemicals are the SIMATIC HMI operator panels and Industrial PCs?
Which panels and flat screens does Siemens currently offer for hazardous areas with potentially explosive atmosphere (Ex2/22)?
Which SIMATIC Panels have the CCC certificate?
How can you determine the "E-Stand" (hardware release) of an operator panel?
What connections are there between the version designations in WinCC flexible?
What support does Siemens AG offer to make products comply with FDA regulations?
What should you watch out with regard to licenses for WinCC flexible and panels?
What options exist for ordering missing plug-in terminal strips for the power supply of panels?
Correction in the French manual for Push-button Panels PP7, PP17-I, PP17-II
What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible 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 flexible
WinCC flexible provides the following options and solutions to fulfill the FDA regulations:

  • Access protection
  • Audit Trail
  • Change Control
  • Electronic signature

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

Examples of local user administration:

  • The individual users and their assignment to user groups are defined in the WinCC flexible configuration.
  • Authorizations with authorization levels based on the user groups are defined in the user administration of WinCC flexible.
  • 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.

Examples of 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

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

Audit Trail (Runtime, Panels)
The Audit Trail is provided by the WinCC flexible/Audit option. WinCC flexible/Audit is for monitoring operator activities in Runtime mode.
Below are examples of fulfilled requirements.

  • Process data (process values, 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 HMI system during operation are recorded in an Audit Trail.
  • Storage of data in a CSV file.
  • Display of evaluation by the "Audit Viewer" (only on PC systems).

Change Control (Engineering System)
Using the WinCC flexible Change Control option it is possible to record changes in the WinCC flexible projects, for example, changes to archive and alarm displays and graphics, definition of access rights etc.

Electronic signature (Runtime, Panels)
WinCC flexible permits users to sign actions electronically. In the Engineering phase, among other things, tags are defined and any changes made to them in Runtime must be confirmed with an electronic signature. The electronic signature may consist of entering a password and a comment. The changes are also recorded in the Audit Trail.

Further information
More information on the topic of GMP (Good Manufacturing Practice) is available at the following link:
http://www.automation.siemens.com/mcms/pharma-industries/de/gmp-validierung

Additional Keywords
Certificate, Directives, Laws, 37940461

 Entry ID:37939984   Date:2013-08-29 
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