English: 21 CFR 11 enabled Rx CheckweigherPolish translation: zgodny z / spełniający wymogi ...21 CFR 11 
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| GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | | English term or phrase: | 21 CFR 11 enabled Rx Checkweigher | | Polish translation: | zgodny z / spełniający wymogi ...21 CFR 11 | | Entered by: | goodline |
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English to Polish translations [PRO]
Tech/Engineering - Electronics / Elect Eng | | English term or phrase: 21 CFR 11 enabled Rx Checkweigher | | 21 CFR 11 enabled Rx Checkweigher |
| | Clarification request(s) and response
| | kompatabilny / zgodny / spełniający wymogi ...21CFR 11 | Explanation:
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 |
| Selected response from:
goodline
Poland
| Note from asker to answererno wlasnie o to chodzi...
dzieki
4 KudoZ points were awarded for this answer |
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11 mins confidence:   |
| 21 cfr 11 enabled rx checkweigher kompatabilny / zgodny / spełniający wymogi ...21CFR 11
Explanation:
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
Reference: http://www.fda.gov/ora/compliance_ref/part11/
Reference: http://www.varianinc.com/cgi-bin/nav?products/spectr/complia...
| goodline
Poland
Works in field
Native speaker of:  Polish
PRO pts in category: 42
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| Note from asker to answererno wlasnie o to chodzi...
dzieki |
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