Validating high complexity lab test methods

19-Jan-2019 20:19

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Analytical methods need to be validated or revalidated The FDA has also published a guidance for the validation of bioanalytical methods (8). The report presents guiding principles for validating studies of both human and animal subjects.

The most comprehensive document is the conference report of the 1990 Washington conference: Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies, which was sponsored by, among others, the American Association of Pharmaceutical Scientists (AAPS), the AOAC and the U. The report has also been used as a basis for the FDA industry guidance document (8).

The validation procedure in this particular article is based on requirements for EU multistate registration.

Wegscheider (13) has published procedures for method validation with a special focus on calibration, recovery experiments, method comparison and investigation of ruggedness. (14) have described how analytical methods are validated in a Japanese QC laboratory.

Starting on April 24, 2003, all non-waived laboratory methods must be validated.

This includes methods that were previously exempted from validation. Westgard reviews the process and procedures of method validation.

I have explored these questions via several surveys, the most recent one was the 2013 How Agile Are You? To truly understand agile testing and quality strategies you must understand how they fit into the overall agile system development lifecycle (SDLC).

Figure 1 depicts a high-level view of the agile lifecycle, showing that the construction phase of agile projects are organized into a series of time-boxes called iterations (in the Scrum methodology they call them "Sprints" and some people refer to them as cycles).

An iterative and incremental (evolutionary) approach to software development which is performed in a highly collaborative manner by self-organizing teams within an effective governance framework, with "just enough" ceremony that produces high-quality solutions in a cost effective and timely manner which meets the changing needs of its stakeholders.

The implication is that your approach to testing/validation also varies depending on where you are in the lifecycle.