Get AUTO8-P - Protocols To Validate Laboratory Information Systems; Proposed Guideline

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice.

The three types of validation are emotional, behavioral and cognitive.

Laboratory Validation is a process that is employed to ensure that laboratory test data and results are consistent, accurate and precise [3].

Data: Validation of the laboratory information system is the continuing process of proving the system fit for its intended use, initially and over time. It consists in defining, collecting, maintaining, and independently reviewing evidence that the system will perform consistently ing to specification.

The specific CLIA definition refers to the requirement that each laboratory that introduces an unmodified FDA-cleared or -approved test must demonstrate and document “that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: accuracy ...

There are eight essential components for method validation: stating the primary objectives, listing the known variables, applying statistics, clarifying the analyte involved, selecting samples, explaining the methods used, performing data analysis, and explaining the results.

Verification is “provision of objective evidence that a given item fulfils specified requirements”, while validation is “verification, where the specified requirements are adequate for the intended use”.

There are eight essential components for method validation: stating the primary objectives, listing the known variables, applying statistics, clarifying the analyte involved, selecting samples, explaining the methods used, performing data analysis, and explaining the results.