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  • Purpose of the validation plan
  • Scope
  • Project documentation development and reviews
  • Schedule/timeline
  • Risk analysis
  • Development and test tools
  • Team resources and responsibilities
  • Development and test environments
  • Test data sets
  • Validation tasks
  • Test documentation
  • Test definition and execution
  • Traceability matrix
  • Metrics for project progress tracking
  • Criteria for release into production
  • Release procedures
  • Required approvals
  • Reporting

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