CAPA _SOP 纠正与预防措施SOP概要1.docVIP

Your Research Site Your Research Address Your Research City Standard Operating Procedure Confidential Proprietary Information Department: Clinical Operations Therapeutic: Your Therapeutic Area(s) Title: Corrective and Preventative Actions SOP No.: SOP-CO-03 Effective Date: Revision: Original Approving Official: Clinical Investigator _______________________________ ______________________________ Name (Printed) Title _______________________________ ______________________________ Signature Date of Approval  Your Research Site COPYRIGHT NOTICE ___________________________________ All material presented is written and owned by Your Research Site. Material provided herein is confidential property and copyright protected by Your Research Site. No part of said material can be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recordings, emailing, or any information storage and retrieval system now or to be invented, without permission in written form from: Your Research Site Your Research Address Your Research City  TABLE OF CONTENTS 1. Purpose Page 4 2. Scope Page 4 3. Background Page 4 4. Procedure Page 5 5. Revision Tracking or Reapproval Page 7 Documentation Attachment(s): Attachment A: CAPA Assessment Tracking Log Page 8 Attachment B: CAPA Assessment Plan Page 9 Attachment C: CAPA Form Page 10 Attachment D: Completed Example of a CAPA Form