Glossary entry (derived from question below)
German term or phrase:
Ergebnisabweichungsprüfung
English translation:
deviation investigation
Added to glossary by
treychic
Feb 17, 2010 21:31
14 yrs ago
2 viewers *
German term
Ergebnisabweichungsprüfung
German to English
Medical
Medical: Pharmaceuticals
quality control
Liebe ProZ-Profis,
Dieser Begriff erscheint in einem SOP bzgl. Qualitätskontrolle.
Zusammenhang:
"Die Ergebnisabweichungsprüfung is sofort nach dem Erkennen eines Ereignisses einzuleiten."
Den Begriff finde ich nirgends im Internet. Was koennte es heissen?
Vielen Dank vorab,
t r e y
Dieser Begriff erscheint in einem SOP bzgl. Qualitätskontrolle.
Zusammenhang:
"Die Ergebnisabweichungsprüfung is sofort nach dem Erkennen eines Ereignisses einzuleiten."
Den Begriff finde ich nirgends im Internet. Was koennte es heissen?
Vielen Dank vorab,
t r e y
Proposed translations
(English)
Proposed translations
1 hr
Bernhard Sulzer
United States
United States
Native in German
United States
High quality at a reasonable price
Native in: German
Works in: English to German, German to English, German, and 1 more.
Related KudoZ points
:
39
Selected
deviation investigation
another way to go:
investigation of projected results
The problem seems to be the word "Ergebnis"
I understand the whole term (Ergebnisabweichung) as "the degree to which the result/performance deviated from what was expected, the objective.
But you won't find it as "result deviation investigation".
I would simply use deviation investigation.
see:
www.ialab.com/Download Forms\Don_FDA_Deviation_Investigatio...
Deviation Investigation
http://www.title21software.com/deviations.html
Deviations and Investigations are both included in the Quality Management module. Each process can stand alone, however often deviations lead to an investigation (and possibly a CAPA) and the event forms can be linked to ensure proper follow-through and closure.
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Note added at 1 hr (2010-02-17 23:07:54 GMT)
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corr (of my comment above): investigation of actual results versus projected ones (targets/objectives)
investigation of projected results
The problem seems to be the word "Ergebnis"
I understand the whole term (Ergebnisabweichung) as "the degree to which the result/performance deviated from what was expected, the objective.
But you won't find it as "result deviation investigation".
I would simply use deviation investigation.
see:
www.ialab.com/Download Forms\Don_FDA_Deviation_Investigatio...
Deviation Investigation
http://www.title21software.com/deviations.html
Deviations and Investigations are both included in the Quality Management module. Each process can stand alone, however often deviations lead to an investigation (and possibly a CAPA) and the event forms can be linked to ensure proper follow-through and closure.
--------------------------------------------------
Note added at 1 hr (2010-02-17 23:07:54 GMT)
--------------------------------------------------
corr (of my comment above): investigation of actual results versus projected ones (targets/objectives)
4 KudoZ points awarded for this answer.
Comment: "Vielen herzlichen Dank!"
+1
34 mins
Error checking
The TAO project: Data Quality Control
TAO data undergo extensive quality control analysis to ensure that they meet ... In addition to the error checking program, daily comparisons are made ...
www.pmel.noaa.gov/tao/proj_over/qc.html
TAO data undergo extensive quality control analysis to ensure that they meet ... In addition to the error checking program, daily comparisons are made ...
www.pmel.noaa.gov/tao/proj_over/qc.html
Peer comment(s):
| agree |
Bernhard Sulzer
: that's one way to go, or maybe error investigation.
42 mins
|
50 mins
Andres Larsen
Venezuela
Venezuela
Native in English
Venezuela
freelance translator
Native in: English 
Works in: Spanish to English, English to Spanish, German to English, and 3 more.
Related KudoZ points
:
56
extreme studentized deviate (ESD) test
Pharmaceurical validation: The ***extreme studentized deviate (ESD) test*** is to be conducted immediately after notification of an event.
Quellen:
[PS] Statistische Ereignisdetektion in Bildfolgen: Adobe PostScript - HTML
grenze bewegen, ausschließlich von Statistikern zu einem Ergebnis geführt wurden oder zu .... 1935] vor, die Abweichung der zu prüfenden Werte xn von ihrem .... ***Extrembereich (engl. extreme studentized deviate, ESD)*** ..... Die Mittelungen über die Indices m und n laufen dabei über den gerade zur Prüfung stehenden ...
archiv.ub.uni-heidelberg.de/volltextserver/.../2002_brocke_phd2002.ps
A Review of Statistical Outlier Methods - Pharmaceutical Technology - Table II: Critical values for the ***extreme studentized deviate test*** (Reference 4). ... Less restrictive inventory control by pharmaceutical companies ...
pharmtech.findpharma.com/.../articleDetail.jsp?... -
[PDF] A Review of Statistical Outlier Methods - : PDF/Adobe Acrobat - Quick view - S Walfish -
increasing emphasis on the OOS procedures of pharmaceutical companies. When a test fails to meet .... The ***extreme studentized deviate test*** is an excellent ...
www.statisticaloutsourcingservices.com/Outlier2.pdf -
Basic statistics and pharmaceutical statistical applications - James E. De Muth - 2006 - Medical - 714 pages
This test is also referred to as ***Extreme Studentized Deviate test or ESD test***. One of the following two formulas is used, depending upon whether x, ...
books.google.com/books?isbn=0849337992...
On the robustness of the extreme deviate test for a single ... - ... Nursing & Midwifery, Pharmaceutical Science, Philosophy ... On the robustness of the ***extreme deviate test*** for a single multivariate outlier against heavy-tailed ... the source of rejection for the multivariate extreme deviate test. ...
www.informaworld.com/smpp/.../content~db=all~content=a78005...
Quellen:
[PS] Statistische Ereignisdetektion in Bildfolgen: Adobe PostScript - HTML
grenze bewegen, ausschließlich von Statistikern zu einem Ergebnis geführt wurden oder zu .... 1935] vor, die Abweichung der zu prüfenden Werte xn von ihrem .... ***Extrembereich (engl. extreme studentized deviate, ESD)*** ..... Die Mittelungen über die Indices m und n laufen dabei über den gerade zur Prüfung stehenden ...
archiv.ub.uni-heidelberg.de/volltextserver/.../2002_brocke_phd2002.ps
A Review of Statistical Outlier Methods - Pharmaceutical Technology - Table II: Critical values for the ***extreme studentized deviate test*** (Reference 4). ... Less restrictive inventory control by pharmaceutical companies ...
pharmtech.findpharma.com/.../articleDetail.jsp?... -
[PDF] A Review of Statistical Outlier Methods - : PDF/Adobe Acrobat - Quick view - S Walfish -
increasing emphasis on the OOS procedures of pharmaceutical companies. When a test fails to meet .... The ***extreme studentized deviate test*** is an excellent ...
www.statisticaloutsourcingservices.com/Outlier2.pdf -
Basic statistics and pharmaceutical statistical applications - James E. De Muth - 2006 - Medical - 714 pages
This test is also referred to as ***Extreme Studentized Deviate test or ESD test***. One of the following two formulas is used, depending upon whether x, ...
books.google.com/books?isbn=0849337992...
On the robustness of the extreme deviate test for a single ... - ... Nursing & Midwifery, Pharmaceutical Science, Philosophy ... On the robustness of the ***extreme deviate test*** for a single multivariate outlier against heavy-tailed ... the source of rejection for the multivariate extreme deviate test. ...
www.informaworld.com/smpp/.../content~db=all~content=a78005...
-1
1 hr
Gabriella Bertelmann
Native in German
&
English
Works in field
Certified Translator/Reviewer 35Y f.t.
Native in: English , German
Works in: German to English, English to German, French to English, and 5 more.
Related KudoZ points
:
8
discrepancy check
"Die Ergebnisabweichungsprüfung is sofort nach dem Erkennen eines Ereignisses einzuleiten."
"a discrepancy check is to be carried out immediately upon event identification"
hope this is helpful. Good luck on your translation
"a discrepancy check is to be carried out immediately upon event identification"
hope this is helpful. Good luck on your translation
Peer comment(s):
| disagree |
Harald Moelzer (medical-translator)
: Sorry, but I never heard of that in a regulatory context
1 day 7 hrs
|
16 hrs
Giovanni Rengifo
Colombia
Colombia
Works in field
Colombia
Traductores Oficiales Cali
Native in: Spanish
Works in: Spanish to English, English to Spanish, German to Spanish, and 2 more.
Related KudoZ points
:
11
investigation of OOS results
OOS= out-of-specification results
alternatively, you could use "investigation of non-conformances"
alternatively, you could use "investigation of non-conformances"
1 day 9 hrs
Harald Moelzer (medical-translator)
Germany
Germany
Native in German
Specializes in field
Germany
Harald Moelzer (medical-translator) 
medical-translator ...the right words!
Native in: German 
Works in: English to German, German to English, French to German, and 1 more.
Related KudoZ points
:
317
Non-conformity review
""non-conformity"" is commonly used in this context
"4.16 Control of quality records
In ISO 9000, quality records are the records that establish that processes were followed and that quality requirements were met. Bydefinition, quality records includes records of:
* Product identification
* Non-conformity review and disposition..."
http://www.methodsandtools.com/archive/archive.php?id=36p2
http://www.theinformationstandard.org/roadmap-dealing-non-co...
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