DAVID TREW CONSULTING LIMITED
+44 (0)1494 700 693
Version 1.6.2
We can help your laboratory verify or validate your test or calibration methods, including:
- Advising on and establishment of specifications against which to access the success of the verification or validation study
- Advising on the most appropriate verification or validation strategy
- Advising on the design of verification or validation experiments
- Preparing verification or validation protocols
- Preparing verification or validation reports
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Method verification is documented evidence that provides a high level of confidence that a laboratory can correctly perform a test or calibration and consistently deliver reliable results meeting predetermined quality characteristics.
Method validation is documented evidence that demonstrates a procedure will consistently produce results that meet predetermined quality characteristics.
Validation of methods not only applies to methods that have been developed in house, it is also necessary to demonstrate that any official method used in the laboratory can meet required quality criteria.
Proper validation of test and calibration methods is of fundamental importance in order to ensure the results created are reliable and trustworthy. It is also of critical importance that the method instructions are written in such a way to ensure that there is no possibility for misinterpretation or misunderstanding.
Verification or validation studies must be carried out following a preapproved study protocol with predetermined acceptance criteria and the results presented in a reviewed and approved document. Study protocols and reports must be written in sufficient detail to allow a trained but uninformed person to reconstruct the study without the need to refer to the originator for clarification.
Having third party input into the method validation life cycle can often identify ambiguities and potential for misunderstandings and misinterpretations that might otherwise be missed, only to come back to haunt the laboratory in the future.
Clause 7.2.1.5 requires a laboratory to verify it can correctly perform all test and/or calibration methods before they are introduced.
Clause 7.2.2 requires a laboratory to validate:
- Non-
standard methods - Laboratory developed methods
- Standard method used outside their intended scope
- Amplifications and modifications to standard methods
To confirm that test methods are fit for their intended use.
METHOD VERIFICATION AND VALIDATION