Regulated GxP Environments
| 14:51 Apr 20, 2005 |
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| English to Spanish translations [PRO] IT (Information Technology) | |||||||
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| 4 | entornos con regulaciones de calidad (de la industria farmacéutica) |
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| 3 | entornos reglamentados por GxP |
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Answers
9 mins confidence: 
| regulated gxp environments entornos reglamentados por GxP Explanation: Valeria: Mirá esta info. Habría que tener un poco más de contexto. Slds. Monica http://www.gxp.co.uk/ Established in 1999 to offer cost effective engineering, production, computing and quality assurance services to the pharmaceutical and biotechnology industries, GxP has rapidly established itself as a trusted and high quality supplier to many blue chip companies. GxP Ltd employs experienced personnel who work with you to deliver your products, engineering projects, computer systems and support services in the most cost effective manner whilst maintaining compliance with all the regulations and standards applicable to the pharmaceutical and biotechnology industries. |
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19 mins confidence:
| regulated gxp environments entornos con regulaciones de calidad (de la industria farmacéutica) Explanation: Esto es lo que encontré, los paréntesis por lo que agrega el segundo link, no todas los entornos regulados de este tipo son en empresas farmacéuticas. Saludos =:) The term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry.* Good Manufacturing Practice, or GMP* Good Engineering Practice, or GEP* Good Laboratory Practice, or GLP* Good Safety Practice, or GSPGMP is the most commonly known instance of GxP. The term GxP is only used in a casual manner, to abstract from the actual set of quality guidelines. en.wikipedia.org/wiki/GxP Guidance for Inspectors Pharmaceutical Inspection Convention Scheme (PIC/S) Good Practices for Computerized Systems in Regulated "GxP" Envronments The purpose of this document is to provide recommendations and background information concerning computerised systems that will be of assistance to inspectors for training purposes and during the inspection of computerised systems. The document will be of assistance to all ‘Good Practice’ Inspectors responsible for inspecting applications in the regulated pharmaceutical sector1; hence the use of the acronym ‘GxP’ in the title. It is recognised that not all companies subjected to GLP inspections are linked to the regulated pharmaceutical sector. However, it is considered that the guidance contained within this PIC/S document may also be beneficial to companies subjected to other regulatory frameworks and GLP inspection The guidance document is intended to provide a logical explanation of the basic requirements for the implementation, validation and operation of computerised systems. With 54 pages the guidance is very detailed. Specifically useful in preparation for inspections is a six page checklist. Considered to be the primary GxP regulatory reference document for using computer computers. http://www.labcompliance.com/info/links/international/intern... |
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