inglés: 21 CFR 11 enabled Rx Checkweigherpolaco translation: zgodny z / spełniający wymogi ...21 CFR 11  KudoZ The KudoZ network provides a framework for translators ... More  |
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| Entrada de glosario (tomada de la pregunta de abajo) | | Término o frase en inglés: | 21 CFR 11 enabled Rx Checkweigher | | Traducción al polaco: | zgodny z / spełniający wymogi ...21 CFR 11 | | Aportado por: | goodline |
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Traducciones de inglés a polaco [PRO]
Tech/Engineering - Electrónica / Ing. elect. | | Término o frase en inglés: 21 CFR 11 enabled Rx Checkweigher | | 21 CFR 11 enabled Rx Checkweigher |
| | Clarification request(s) and response
| | kompatabilny / zgodny / spełniający wymogi ...21CFR 11 | Explicación:
Title 21 Code of Federal Regulations (21 CFR Part 11)
Electronic Records; Electronic Signatures
21 CFR Part 11 compliance for spectroscopy instruments:
When you need to achieve compliance to the complex requirements of the U.S. Food and Drug Administration (FDA) 21 CFR Part 11 rule on electronic records and electronic signatures...
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Note added at 18 mins (2004-12-01 13:14:38 GMT)
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IMHO: chodzi o \"oprogramowanie\" tego (tej wersji) weightcheckera
enabled = To make operational; activate
21 CFR Part 11 Compliance
For customers working in an environment regulated by the FDA, it is necessary that software be compliant with regulations adopted by the FDA. These regulations are contained in the Code of Federal Regulations (CFR), Title 21, Part 11, and are entitled “Electronic Records; Electronic Signatures”. The rules change significantly how computer-generated data is to be stored and used, and aim to make electronic records comparable to a lab notebook in terms of providing a traceable record that is immutable.
http://www.wyatt.com/solutions/services/21CFRComp.cfm |
| Respuesta elegida de:
goodline
Polonia
| Nota de quien pregunta a quien contestano wlasnie o to chodzi...
dzieki
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11 minutos Nivel de confianza:   |
| | 21 cfr 11 enabled rx checkweigher kompatabilny / zgodny / spełniający wymogi ...21CFR 11
Explicación:
Title 21 Code of Federal Regulations (21 CFR Part 11)
Electronic Records; Electronic Signatures
21 CFR Part 11 compliance for spectroscopy instruments:
When you need to achieve compliance to the complex requirements of the U.S. Food and Drug Administration (FDA) 21 CFR Part 11 rule on electronic records and electronic signatures...
--------------------------------------------------
Note added at 18 mins (2004-12-01 13:14:38 GMT)
--------------------------------------------------
IMHO: chodzi o \"oprogramowanie\" tego (tej wersji) weightcheckera
enabled = To make operational; activate
21 CFR Part 11 Compliance
For customers working in an environment regulated by the FDA, it is necessary that software be compliant with regulations adopted by the FDA. These regulations are contained in the Code of Federal Regulations (CFR), Title 21, Part 11, and are entitled “Electronic Records; Electronic Signatures”. The rules change significantly how computer-generated data is to be stored and used, and aim to make electronic records comparable to a lab notebook in terms of providing a traceable record that is immutable.
http://www.wyatt.com/solutions/services/21CFRComp.cfm
Referencia: http://www.fda.gov/ora/compliance_ref/part11/
Referencia: http://www.varianinc.com/cgi-bin/nav?products/spectr/complia...
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