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Computer System Validations are the mandatory and indestructible audit trail that the Food and Drug Administration (FDA) considers to apply to: the validation of medical device software or, the validation of software (systems) used to design, develop, or manufacture medical devices

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[DOI] [PubMed] [Google Scholar] 67.Blatt S, Voelxen N, Sagheb K, Pabst AM, Walenta S, Schroeder T, et al