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21 CFR 11 enabled Rx Checkweigher

Polish 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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12:56 Dec 1, 2004
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
Robert Pranagal
Local time: 15:58
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
Local time: 15:58
Grading comment
no wlasnie o to chodzi...
dzieki
4 KudoZ points were awarded for this answer

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Summary of answers provided
4kompatabilny / zgodny / spełniający wymogi ...21CFR 11
goodline


Discussion entries: 1





  

Answers


11 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
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
Local time: 15:58
Works in field
Native speaker of: Native in PolishPolish
PRO pts in category: 42
Grading comment
no wlasnie o to chodzi...
dzieki
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