Validation Master Plan Checklist

A validation master plan sets the rules everyone else follows. This checklist walks the sections a VMP should contain and the questions each section has to answer.

What's inside

  • Scope, site boundaries and applicable regulations
  • Governance, roles, responsibilities and approval authority
  • System inventory and criticality classification approach
  • Risk management methodology and acceptance criteria basis
  • Deliverable set and documentation hierarchy
  • Deviation, change control and requalification triggers
  • Periodic review and plan maintenance

Who it's for

Validation leads, quality managers, site engineering

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