The blueprint for your validation, this customizable document tracks the activities, deliverables, responsibilities, and strategies to be performed during the validation. It defines the scope of the project as well as stating what is out of scope of the validation work. It also acts as a central repository for appropriate approvals, revision history, standard operating procedures, and references.

Template sections include:

  • Introduction (system description, scope, definitions and acronyms, reference documents)
  • Validation management (approach, risk analysis, participants, deliverables, record management)
  • Validation deliverables (other templates available from CSols)
  • Risk assessment
  • Testing phases and documentation
  • Acceptance criteria and system release
  • Maintaining the validated state
  • Document management
  • References


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    • Validation Plan

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