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Siemens Industry Online Support
Siemens AG
Type bericht: FAQ, ID van bericht: 37939948, Datum bericht: 29.08.2013
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What support does Siemens AG offer to make products comply with FDA regulations?

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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
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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

Nota's in verband met security
Ter bescherming van installaties, systemen, machines en netwerken tegen digitale dreigingen is het noodzakelijk om een alomvattend 'Industrial Security' concept te implementeren (en continu te handhaven) dat overeenkomt met de huidige stand van de techniek. De producten en oplossingen van Siemens vormen slechts een deel van een dergelijk concept. Meer informatie over 'Industrial Security' vindt u op
http://www.siemens.com/industrialsecurity.
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