Transcription of QSIT Points to Consider-Design ControlFINAL
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QSIT Points to Consider-Design ControlFINAL
Points TO consider WHEN PREPARING FOR AN FDA. INSPECTION UNDER THE QSIT design CONTROLS. SUBSYSTEM. MAY 15, 2003. Bringing innovation to patient care worldwide 1200 G Street NW, Suite 400. Washington, DC 20005 3814. Tel: 202 783 8700. Fax: 202 783 8750. ACKNOWLEDGEMENT. This document was authored by Frederick F. Schweitzer, Welch Allyn, Inc. Assistance was provided by: Annette Hillring Frances Akelewicz Nancy Singer Pamela J. Weagraff Hillring & Associates, Inc. Practical Solutions, LLC AdvaMed MediSpectra, Inc Many other people also contributed to the ideas contained in the document. We thank the following industry officials for serving as members of the review committee: Mark Allen, NetRegulus Richard Andersen, Siemens Medical Solutions Mary Armstrong, Armstrong Consulting Edwin Bills, Hill-Rom Company, Inc.
5 of 21 Design Controls Subsystem - Questions and Answers Q.1 During a QSIT inspection, when an FDA investigator requests to inspect a device
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