Structure of Self Assessment Questionnaire (SAQ)

This SAQ is composed of 7 sections that contain important criteria to assess to assess the readiness of your test to enter into validation.

  • The section Test method description concerns the test system, the cellular environment, the exposure scheme and the technical requirements in order to assess Technical Readiness Criteria (TRC).
  • The section Operational readiness and data management investigates the laboratory's ability to produce and analyse data in a validation process.
  • The section Reproducibility and transferability investigates the availability of data on repeatability, reproducibility and the transferability of the method.
  • The section Historical data investigates data on positive and negative controls.
  • The section Standard Operating Procedures (SOPs) concerns the templates or worksheets that should be written and prepared to allow the implementation of the method in a new (naive) lab.
  • The section Relevance of the method investigates the regulatory relevance of the method
  • The section Laboratory resources for prevalidation evaluates the time and resources available.

General information
Project Title/Method Name

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