Glossary entry

Spanish term or phrase:

Aprobado con desvíos

English translation:

Approved with deviations

Added to glossary by Micaela Pronsky (X)
Feb 3, 2012 18:57
12 yrs ago
3 viewers *
Spanish term

Aprobado con desvíos

Spanish to English Medical Medical: Pharmaceuticals
Además, se establecen y mantienen los registros de los proveedores calificados disponibles para gestionar las compras; y de los proveedores evaluados, con el correspondiente status de la evaluación y resultado de la calificación: Aprobado, Aprobado con desvíos o Restringido.
Cada dos años se realizará un programa de auditorías con visita a instalaciones, en caso de corresponder, a proveedores y terceristas; donde se indicará las auditorias programadas para dicho periodo. En el programa se indicará el seguimiento de la realización de las auditorias programadas así como la emisión de informe y pedido de acciones correctivas conforme a evaluación inicial realizada; así como la reprogramación de auditorías planificadas no concretadas conforme al plan.


Muchas gracias por su ayuda
Proposed translations (English)
3 +1 Approved with deviations
4 approved with changes

Discussion

Micaela Pronsky (X) (asker) Feb 4, 2012:
Your explanations are always helpful thank so much
Stephen Volante Feb 4, 2012:
"deviations" vs. "changes" I think more information about the source text would clarify the situation.

The Word file at http://tiny.cc/v88dv is a guide to a Peoplesoft tool for managing submissions to Institutional Review Boards (IRBs) or Institutional Animal Care and Use Committee (IACUCs). "Approved with Deviations from Federal Guidelines (e.g., deviations to consent requirements as described in 45 CFR 46.116-117" is one possible IRB or IACUC decision. This file is the only result from a Google search for "Approved with deviations."

It isn't clear what Micaela is translating, but it appears to be related to approval of pharmaceutical product. If the reviewing body that Micaela is translating for approves applications "with deviations" from 45 CFR 46 (US DHHS regulations), then "deviations" is probably the right choice, but maybe the reviewing body doesn't even consider 45 CFR 46. I think it depends on the context of the text Micaela is working on and who will review it. I spent 2 years with an NGO translating and managing submissions to Harvard IRBs, which did not "approve with deviations". Their decisions were "approval," "disapproval," "deferral," or "modifications required."

I hope this helps.

Proposed translations

+1
3 mins
Selected

Approved with deviations

I went literal in my google search and there are some hits in context:

http://tiny.cc/v88dv

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Note added at 6 mins (2012-02-03 19:03:45 GMT)
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M3) Approved with Deviations from Federal Guidelines (e.g., deviations to consent requirements as described in 45 CFR 46.116-117): the system notifies the department, and department of the approved application and non-standard protocol requirements and the IRB-A inputs the IRB Expiration Date;
http://tiny.cc/6xvyp
Note from asker:
thanks, I found it in my google search, thank you again
*I didnt find it in my google research!
Peer comment(s):

agree GABRIELA SILVIA MEZOÑA : TOTALLY AGREE !
8 mins
Thanks, Gabriela :)
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4 KudoZ points awarded for this answer.
17 hrs

approved with changes

Sounds more natural to my ENS ears. Googles better FWIW.
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