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link 16.08.2005 9:30 |
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Subject: FDA The stored data must be retrievable and legible at all times for FDA inspection.FDA mandates that a password has a maximum validity of 90 days, that every password can only be used once. Здесь говорится о программном обеспечении для прибора. |
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FDA - "Food and Drug Administration" (U.S. Department of Health and Human Services Food and Drug Administration) а ти уверен, что речь идет об обеспечений прибора? |
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на етом адрессе: http://www.21cfrpart11.com/files/fda_docs/part11_final_guidanceSep2003.pdf нашел текст:"In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health." вот поетому думаю, что в твоем тексте речь идет о каких нубудь требовании етой администрацией... |
| волдемор дело говорит (с) |
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link 16.08.2005 10:59 |
| Да это оно, спасибо! |
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не за что! :-) сори,но на моей клавиатуре нет некоторие символи русской азбуки - все-таки я из Болгарии :-) |
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