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PubMed · 12122896

[Computer system validation. The quality assurance procedure].

Valentine Anthony Sforza
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Abstract

The use of computerized systems in preclinical studies has increased over the last ten years. This fact has caused dramatic changes in the way raw data are used in studies. Regulatory authorities, in fact, now require that computerized systems used during preclinical studies be validated. Quality assurance was given the task of organizing an approach to this challenge. Above all, this process applies to all company functions, from test facility management to technical staff. Moreover, various systems may be encountered during the process where the operating systems and the technologies used may be different. Another difficulty may be the lack of resources, changes requested by users or regulatory updates of legislation. Last but no least, archiving should not be underestimated.

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Clinical Laboratory TechniquesComputer SystemsDrug Evaluation, PreclinicalForms and Records ControlGuideline AdherenceItalyManagement AuditMethodsQuality ControlResearchResearch DesignToxicologyEnglish AbstractJournal ArticleReview

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Valentine Anthony Sforza. 2002. [Computer system validation. The quality assurance procedure].. https://pubmed.ncbi.nlm.nih.gov/12122896/

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