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Especially in complex validations, the validation matrix facilitates oversight. It is a structured document or tool that represents the relationship between various validation requirements and the elements to be validated, such as systems, processes, or equipment. This matrix helps ensure that all aspects of a project comply with regulatory and internal company standards.

Typically, a validation matrix includes information on:

  • Validation Requirements: Specific criteria that need to be met based on regulatory guidelines and company standards.
  • Elements to be Validated: Listing of the systems, processes, or components that need to be validated.
  • Tests and Criteria: Methods and procedures applied to confirm the fulfillment of the requirements.
  • Documentation: References to the documents that contain the results and evidence of the validation.
  • Responsibilities: Assignment of tasks to specific individuals or teams for conducting validation activities.

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