validation plan template- i s p e（验证计划模板- i s p e）.docVIP

Authors Signature: Your signature indicates that this document has been prepared in accordance with existing project standards and adequately reflects the tasks and deliverables necessary for validation of the equipment name Authored By: Typed/Printed Name, Title Signature Date Unit Reviewers Signature: Your signature indicates that, you have reviewed this document and that it accurately and completely reflects the tasks and deliverables necessary for validation of the equipment name. Reviewed By: Typed/Printed Name, Title Signature Date Unit Typed/Printed Name, Title Signature Date Unit Typed/Printed Name, Title Signature Date Unit Quality Control/Compliance Approvers Signature: Your signature indicates that this document complies with reference Validation Master Plan, company standards or guidelines; and that the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements, and current Good Manufacturing Practices. Approved By: Typed/Printed Name, Title Signature Date Unit Typed/Printed Name, Title Signature Date Unit Revision History Revision Revision Date Reason for Revision/Change Request Revised By 0 04-DEC-2002 Original Release Michael T. Filary 1 16-JAN-2003 Updated the JETT logo on the cover page. Michael T. Filary Table of Contents 1. Introduction 5 1.1 Purpose 5 1.2 Policy Compliance 5 1.3 Scope of Validation 5 1.4 Objectives 6 1.5 Periodic Review 6 2. Organizational Structure 7 3. GxP Criticality Assessment 7 3.1 GxP Criticality Assessment - Requirements 7 3.2 GxP Criticality Assessment - Procedures 8 3.3 GxP Criticality Assessment – Current Status 8 4. Validation Strategy 9 4.1 Life Cycle 9 4.2 Risk Assessment 9 4.3 Hardware Categories 9 4.4 Software Categories 9 4.5 Project Inputs/Outputs for Stages 10 4.6 Acceptance Criteria for Stages 10 5. Validation Deliverables 10 5.1 Traceability and Linkages 11 5.2 M