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The aim of this guideline document is to facilitate the straight forward development of a Quality System in any research institution, irrespective of discipline, which has no previous experience of such process. A structure of ten subject matter sections has been adopted so as to provide a simple, pragmatic "get started" model for Quality systems in Non-Regulated Scientific Research. Evaluation of risk should drive the order of their implementation.
RQA Working Party on Quality in Non-Regulated Research
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June 2008
Management of the Training and Competency of Personnel in GxP and Research Environments
Quality in Research Booklet