validation plan template- talk talk business（验证计划模板,我们谈谈生意）.docVIP

Validation Plan Template Document No: Template_VP_0001_01 Prepared by: Author Date: DD-MMM-YYYY Version: 1.0 Document Approval Name Role Date Signature Author Author IT Validation Client Document Control Version Author Date Description 1.0 Author DD-MMM-YYYY First Version Table of Contents 1 Introduction 5 1.1 Objective 5 1.2 Scope 5 1.3 Definitions 5 1.4 References 5 2 Responsibilities 7 2.1 Approval of deliverables 7 2.2 Validation working parties 7 2.3 Client group responsibilities 7 2.4 IT group responsibilities 7 2.5 Validation group responsibilities 7 3 System Description 8 4 Validation Activity Requirements 9 4.1 Validation Approach 9 4.2 Validation Methodology 9 4.2.1 Validation Plan (VP) 9 4.2.2 Vendor Audit 9 4.2.3 Design Qualification 9 4.2.4 Installation Qualification (IQ) [OQ Testing and Production] 9 4.2.5 Operational Qualification (OQ) 10 4.2.6 Validation Summary Report 11 4.2.7 Validation Change Control 11 4.2.8 Production Qualification (PQ) 12 5 Assumptions, Exclusions and Limitations 12 5.1 Compliance Requirements 12 6 Project Validation Organization 13 7 Validation Documents Required 14 7.1 Decommissioning 15 8 Acceptance Criteria 17 9 Validation Project Milestones 18 10 On-going Validation Requirements 19 10.1 SOPs related to Validation and Development 19 10.2 Data Preparation 19 10.3 Ongoing Maintenance 19 10.4 Software Updates, Correction Packages and Patches 19 Introduction Objective Insert details of the objectives of conducting the Validation Plan. For example, to validate system 1234. Scope Insert a description of the scope of the Validation Plan. The description should include: Any specific phases on the system implementation Any specific servers that the system will reside on The software development life cycle (SDLC used) A definition of the post implementation validation process PQ Definitions Provide the definition of all terms and acronyms. References This document conta