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TITLE:
VALIDATION PLAN FOR THE <
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File Name: 2232836.docLast Save Date: 23-Jun-2007Print Date: 3/4/08
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VALIDATION PLAN FOR THE <
Equipment Name
, ID#
12345
>Author's Signature:
Your signature indicates that this document has been prepared in accordance with existing project standards andadequately reflects the tasks and deliverables necessary for validation of the <
equipment name
>
Authored By:
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Reviewer's Signature:
Your signature indicates that, you have reviewed this document and that it accurately and completely reflects the tasksand deliverables necessary for validation of the <
equipment name
>.
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Quality Control/Compliance Approver's 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.
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File Name: 2232836.docLast Save Date: 23-Jun-2007Print Date: 3/4/08
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Revision History
RevisionRevision DateReason for Revision/Change RequestRevised By
004-DEC-2002Original ReleaseMichael T. Filary116-JAN-2003Updated the JETT logo on the cover page.Michael T. Filary
Table of Contents
1. Introduction..................................................................................................................................................51.1 Purpose...................................................................................................................................................51.2 Policy Compliance..................................................................................................................................51.3 Scope of Validation.................................................................................................................................51.4 Objectives...............................................................................................................................................61.5 Periodic Review......................................................................................................................................62. Organizational Structure..............................................................................................................................73. GxP Criticality Assessment..........................................................................................................................73.1 GxP Criticality Assessment - Requirements..........................................................................................73.2 GxP Criticality Assessment - Procedures...............................................................................................83.3 GxP Criticality Assessment – Current Status........................................................................................84. Validation Strategy.......................................................................................................................................94.1 Life Cycle...............................................................................................................................................94.2 Risk Assessment.....................................................................................................................................94.3 Hardware Categories..............................................................................................................................94.4 Software Categories................................................................................................................................94.5 Project Inputs/Outputs for Stages.........................................................................................................104.6 Acceptance Criteria for Stages.............................................................................................................105. Validation Deliverables..............................................................................................................................105.1 Traceability and Linkages....................................................................................................................115.2 Master List of all Validation Products and Supporting Documentation..............................................115.3 User Requirements Specification (URS)..............................................................................................115.4 Functional Requirement Specification (FRS)......................................................................................115.5 Configuration Management and Change Control Documentation.....................................................115.6 Vendor Qualification documentation...................................................................................................115.7 Design Specifications...........................................................................................................................125.8 Testing and Verification Requirements Documentation......................................................................125.9 System Security....................................................................................................................................135.10 Operational Support...........................................................................................................................135.11 Business Continuity Plan...................................................................................................................145.12 Disaster Recovery, Backup and Restoration......................................................................................145.13 System Acceptance – Final Report.....................................................................................................145.14 <List any additional validation products required>..........................................................................146. Acceptance Criteria....................................................................................................................................15
File Name: 2232836.docLast Save Date: 23-Jun-2007Print Date: 3/4/08
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