We can help your laboratory validate your analytical methods, including :
Advising on and establishment of specifications against which to access the success of the validation study
Advising on the most appropriate validation strategy
Advising on the design of validation experiments
Preparing validation protocols
Preparing validation reports
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Analytical method validation is documented evidence that demonstrates an analytical procedure will consistently produce results that meet predetermined quality characteristics.
Validation of analytical 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 analytical test 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.
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 7.2.2 requires a laboratory to validate:
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.