Turn around time The required TAT List any other factors that may affect the utility of the test for the intended Other considerations purpose. Expected performance can be mentioned here. 2. Validation of new system System name Internal descriptive name Reference Internal ref. Applicability of Is what is being tested appropriate and sufficient to achieve the desired measurements results? Compared with specification. Detail any test specific selectivity issues together with limitations and/or control measures taken to ensure test utility. A validation work plan (section Selectivity 3) should be drawn up for any specific potential selectivity issues that cannot be eliminated by limitation or control measure[s]. Detail any test specific interference factors together with limitations and/or control measures taken to ensure test utility. A validation work plan (section Interferences 3) should be drawn up for any specific potential interference that cannot be eliminated by limitation or control measure[s]. Detail any test specific cross-reactivity together with limitations and/or control measures taken to ensure test utility. A validation work plan (section Cross-reactivity 3) should be drawn up for any specific potential cross-reactivity that cannot be eliminated by limitation or control measure[s]. Authorisation Name Signature Date Investigator Authoriser
Turn around time The required TAT Other considerations List any other factors that may affect the utility of the test for the intended purpose. Expected performance can be mentioned here. 2. Validation of new system System name Internal descriptive name Reference Internal ref. Applicability of measurements Is what is being tested appropriate and sufficient to achieve the desired results? Compared with specification. Selectivity Detail any test specific selectivity issues together with limitations and/or control measures taken to ensure test utility. A validation work plan (section 3) should be drawn up for any specific potential selectivity issues that cannot be eliminated by limitation or control measure[s]. Interferences Detail any test specific interference factors together with limitations and/or control measures taken to ensure test utility. A validation work plan (section 3) should be drawn up for any specific potential interference that cannot be eliminated by limitation or control measure[s]. Cross-reactivity Detail any test specific cross-reactivity together with limitations and/or control measures taken to ensure test utility. A validation work plan (section 3) should be drawn up for any specific potential cross-reactivity that cannot be eliminated by limitation or control measure[s]. Authorisation Name Signature Date Investigator Authoriser
guidelines_for_validation.docx