The operational qualification protocol verifies, with a high degree of assurance, that the instrument or system meets the desired functionality of the end users. Included in the template are instructions for who is responsible for what pieces of the qualification, and guidance for what needs to be tested in this stage of the validation process.

Template sections include:

  • Approvals prior to execution
  • Purpose
  • Scope
  • System description
  • Responsibilities, definitions, acronyms
  • Reference documents
  • Approach
  • Procedure
  • Prerequisites
  • Testing documents
  • Qualification summary
  • Post-execution approvals
  • Appendixes (Signature table, deviation forms, deviation summary data sheet)

Users may customize the template by adding approvers, tests, and supplementary materials.


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    • Operational Qualification Protocol

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