Get Standardized Protocol For Method Validation/Verification

A) Prospective validation (or premarket validation) B) Retrospective validation. C) Concurrent validation. D) Revalidation.

Validation methods Validation MethodDescriptionRange checkChecks the data falls between an acceptable upper and lower value, within a set rangeType checkChecks that the data entered is of an expected type, e.g. text or a numberLength checkChecks the number of characters meets expectations, e.g. an 8 character password2 more rows

A few verification methods are inspection, code review, desk-checking, and walkthroughs. A few widely-used validation methods are black box testing, white box testing, integration testing, and acceptance testing. The quality assurance (QA) team would be engaged in the verification process.

ISO 16140-2 is the base standard for alternative methods validation and is cross-referenced by the other parts of the 16140 series. It includes two phases, the method comparison study and the interlaboratory study, with separate protocols for the validation of qualitative and quantitative microbiological methods.

The most common techniques used fall into two categories: data validation and data verification.

Method validation of test procedures is the process by which one establishes that the testing protocol is fit for its intended analytical purpose. This process has been the subject of various regulatory requirements.

The four fundamental methods of verification are Inspection, Demonstration, Test, and Analysis.

ISO/IEC 17025 defines validation as “the confirmation by examination and the provision of objective evidence that the particular requirements for specific intended use are fulfilled”. Validation is specifically intended to be used as an analytical requirement.