Conduct of an internal review as part of the Application Integrity Policy.
This article reflects the authors' experiences in the conduct of a third-party internal review of a device manufacturer as part of the Application Integrity Policy. The experiences are discussed in terms of recommended operational procedural issues from the vantage point of the sponsor and consultant(s). Issues pertaining to the sponsor, such as employee cooperation, work priorities and responsibilities, the assembly of data to be audited, and the need to have an orientation program for the consultant(s), will be discussed. Likewise, issues pertaining to the consultant(s), such as their expertise, the need for a clearly defined audit plan and work assignments, the handling of interpersonal conflicts if they arise, and the content of the audit report, will be discussed.
Biometric Research Institute, Inc, Arlington, VA 22209, USA.
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Hirsch
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Kaiser
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La Douceur
D003253:Consultants; D018795:Device Approval / Q000592:standards*; D004282:Documentation; D005161:Facility Regulation and Control; D006801:Humans; D007221:Industry; D007373:Interinstitutional Relations; D008330:Management Audit; D015871:Scientific Misconduct; D014342:Truth Disclosure; D014481:United States; D014486:United States Food and Drug Administration