Validation and Qualification
By validating, we are evaluating and documenting the performance of a test method to ensure that it meets the requirements for accuracy, precision, specificity, sensitivity, and reproducibility for its intended use.
This process provides evidence that a test method is fit for its purpose and can be used to make reliable and consistent measurements.
My test method validation includes a series of experiments, data analysis, and reports documenting the results.
It is important to validate test methods in order to ensure the quality and reliability of test results and to make informed decisions based on the results.
The focus:
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Equipment and Facilities Qualifications
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Process & Cleaning Validations
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Technology Transfer
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Test Method Validations
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LIMS Validation
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Computer System Validations
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Clean Room Designs and Validation