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.