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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?
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?
Mobile 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?
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
Basic 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?
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?
Comfort Panels -- Product information -- Technical data and ordering information
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 frame colors are used for the SIMATIC Panels and SIMATIC Panel PCs?
Which panels are certified for shipbuilding?
Which panels are certified for the FM explosion protection standard for North America?
Where are the current declarations of conformity to be found for SIMATIC HMI panels (CE, UL, cUL, GOST)?
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?
Which SIMATIC Panels have the CCC certificate?
WinCC (TIA Portal) -- Product information -- Technical data and ordering information
Which ports are used by WinCC Advanced, WinCC Runtime Advanced, WinCC Runtime Professional, Basic Panels, Comfort Panels, Panels and IPC?
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 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?
Part number:

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"

Additional Keywords
Certificate, Directives, Laws

 Entry ID:37940461   Date:2013-08-29 
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