Vmp Scada Gamp 4 or 5

Hi! Can anyone help me With A good exampke of A master plan template for A computerized Scada system?:flushed:

Just to be clear, there are 2 types of plans: master validation plans (MVP or VMP) and (product) validation plans. The MVP describes how you, as a company, approach validation (how you make decisions as to what is to be validated, approaches to validation, etc.). Here’s AN outline of such a doc:

  1. Scope
  2. Background
    2.1. Definitions and Acronyms
    2.2. Reference Documents
  3. Roles and Responsibilities
  4. Facility Overview
  5. General Approach
    5.1. System Impact Assessments
  6. Validation Approach
    6.1. Organization
    6.2. Requirements
    6.3. Planning and Preparation
    6.4. Validation Execution
    6.5. Validation Completion
    6.6. Change Management
    6.7. Post-Deployment Monitoring
  7. Approaches
    7.1. Prospective
    7.2. Retrospective
    7.3. Concurrent
  8. Methods
    8.1. Installation Qualification (IQ)
    8.2. Operational Qualification (OQ)
    8.3. Performance Qualification (PQ)
  9. Inventory & Classifications

The validation plan for a particular product (e.g., a computerized SCADA system) describe how validation is achieved and maintained for that product. Here’s AN outline for a product validation plan:

  1. Introduction
    1.1 Purpose
    1.2 Scope of Validation
    1.3 Objectives
    1.4 Periodic Review
  2. Organizational Structure
  3. GxP Criticality Assessment
  4. Validation Strategy
    4.1 Life Cycle
    4.2 Risk Assessment
    4.3 Hardware Categories
    4.4 Software Categories
  5. Validation Deliverables
    5.1 Traceability and Linkages
    5.3 User Requirements Specification (URS)
    5.4 Functional Requirement Specification (FRS)
    5.5 Configuration Management and Change Control Documentation
    5.6 Vendor Qualification documentation
    5.7 Design Specifications
    5.8 Testing and Verification Requirements Documentation
    5.9 System Security
    5.10 Operational Support
    5.11 Business Continuity Plan
    5.12 Disaster Recovery, Backup and Restoration
    5.13 System Acceptance – Final Report
  6. Acceptance Criteria
  7. Change Control
    7.1 Pre-Implementation Changes
    7.2 Post-Implementation Changes
  8. Documentation Management
  9. Maintaining the Validated State
  10. System Retirement

There are quite a few resources you can use to help guide you (and at the risk of advertising, some are available at this site). Be sure you have sufficient training and expertise before embarking on a validation. Otherwise, you may be incomplete or do unnecessary work.

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