Get Validation And Verification In Laboratory

The lab must have a management system consistent with that described in ISO/IEC 17025:2005. The analysts must be adequately trained: • The analyst must have the appropriate knowledge, experience, and training to perform the procedure.

ISO/IEC 17025 requires laboratories to validate methods that they use. This includes non-standard methods, laboratory-developed methods and standard methods.

For ISO/IEC 17025, method validation is a key requirement to deliver meaningful data. Standard and in-house methods need validation and verification. Likewise, validation is a planned activity that encompasses parameters. Meanwhile, validation is incomplete if there's no statement of fitness for purpose.

ISO 17468 is a closely linked International Standard, which establishes technical rules for the development or revision and validation of standardized reference methods.

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.

ANSWER. The four fundamental methods of verification are Inspection, Demonstration, Test, and Analysis. The four methods are somewhat hierarchical in nature, as each verifies requirements of a product or system with increasing rigor.

GENERAL REQUIREMENTS The lab must have a management system consistent with that described in ISO/IEC 17025:2005. The analysts must be adequately trained: • The analyst must have the appropriate knowledge, experience, and training to perform the procedure.

In conclusion, method validation is usually applied to an “in-house method” developed by a laboratory; while method verification is applied to a “compendia method or previously validated method” when it is being use in a particular laboratory for the first time.