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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 ES -- Product information -- General information
Does WinAC MP 2008 for WinCC flexible 2008 run in Windows 7?
Why can you not select the SIMATIC HMI Panel PC Ex as operator panel in WinCC flexible 2008?
What should you watch out for when installing WinCC flexible 2008 SP3 or WinCC V11 SP2 on an HP notebook?
How do you make printouts on different printers in WinCC flexible PC Runtime?
How can you exchange data between USB storage devices on the Thin Client with an active RDP connection?
What are the functional differences between the different SIMATIC panels?
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 products comply with FDA regulations?
What different CPU technologies are available in the PC sector and what are the advantages offered by SIMATIC PCs with Intel® Core™ 2 Duo processors when using SIMATIC software?
How do you send customer projects to Technical Support?
Why are PDF documents not displayed properly on the MP377?
Which GSD files are there for the Profibus DP operator panels?
Which GSDML files are there for the operator panels for Profinet IO?
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 /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?
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?
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 -- Determining performance and quantity frameworks
What are the functional differences between the different SIMATIC panels?
Which HMI components can you connect with S7-200 CPU and what should you watch out for when doing so?
Why do you get a warning when generating the block FB163, F_FB_RNG_16 and why cannot you load the block when using the Mobile Panel 277F IWLAN and an S7 CPU 315F (with PROFINET)?
What support does Siemens AG offer to make products comply with FDA regulations?
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
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
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?
Comfort 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 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 functions can you use with the different WinCC (TIA Portal) Engineering versions (Basic/Comfort/Advanced/Professional)?
How do you load the 3D, CAx and ePLAN data for the SIMATIC products?
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 products comply with FDA regulations?
Part number:

Food & Drug Administration (FDA)


FDA logo

The FDA is the USA authority for licensing drugs and is under the Ministry of Health. The FDA was founded in 1927 with headquarters in Rockville (Maryland).

The FDA's task is to protect public health in the USA. It regulates the safety and effectiveness of human and animal pharmaceuticals, biological products, medical products, food and radiating devices. The regulations apply to products produced in the USA and imported products.
The FDA is comparable with the TÜV and Ministry of Health in Germany.

Important regulation for Siemens AG products
On August 20, 1997, the FDA's rule 21 CFR Part 11 on electronic records and signatures came into force. 21 CFR Part 11 (in brief: Part 11) defines the acceptance criteria of the FDA for the use of electronic records and signatures instead of drawings in paper form and handwritten signatures on paper.

The requirements include the following:

  • Validation
  • Records of operator actions
  • Retention/Protection/Reproducibility/Retrievability
  • Access protection
  • Electronic signature (certification of equality)

Detailed information on the single products and solutions are available at the following links.
 
Description Entry ID
Information about WinCC. 37940022
Information about WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible. 37939984
Information about WinCC (TIA Portal), WinCC Runtime Advanced and panels that can be configured with WinCC (TIA Portal).  37940461
Table 01

Further information about GMP
More information on the topic of GMP (Good Manufacturing Practice) is available at the following link:
http://www.automation.siemens.com/pharma

Additional Keywords
Certificate, Directives, Laws

 Entry ID:37939948   Date:2013-08-29 
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