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Monday, 17 May 2010

Computer System Impact / Risk Assessment

Posted on 13:21 by Unknown
Purpose of Risk AssessmentThe purpose of the risk assessment process is to ensure that the validation (quality) effort is directed at the systems that have the potential to impact product quality, efficacy and data integrity (throughout this article referred to as Product Quality).
Initial Risk AssessmentsIn the ISPE Commissioning and Qualification Guide the approach to an initial impact
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